Trial Outcomes & Findings for A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects With NUT Midline Carcinoma (NMC) and Other Cancers (NCT NCT01587703)
NCT ID: NCT01587703
Last Updated: 2020-03-16
Results Overview
Pulse rate was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
196 participants
Primary outcome timeframe
Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure
Results posted on
2020-03-16
Participant Flow
A total 196 participants were enrolled and randomized in the Part 1 QD (65 participants), Part 1 BID (19 participants), Besylate Substudy (10 participants), and Part 2 (102 participants) groups.
This was a 2-Part study conducted in 8 countries-Part 1 (dose-escalation) and Part 2 (dose expansion). A besylate sub-study (four period, crossover) was conducted in 10 participants in the United States.
Participant milestones
| Measure |
Part 1: GSK525762 2 mg QD
Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.
|
Part 1: GSK525762 4 mg QD
Participants were administered once daily oral dose of 4 mg GSK525762
|
Part 1: GSK525762 8 mg QD
Participants were administered once daily oral dose of 8 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 20 mg BID
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 2: Participants With NMC
Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762.
|
Part 2: Participants With SCLC
Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762
|
Part 2: Participants With CRPC
Participants with Castrate-Resistant Prostate Cancer (CRPR) were administered continuous once daily oral dose of 75 mg GSK525762
|
Part 2: Participants With TNBC
Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762.
|
Part 2: Participants With ER+BC
Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762
|
Part 2: Participants With GIST
Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762.
|
80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes
Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.
|
80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes
Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part1 QD(Median Exposure of 1.38months)
STARTED
|
3
|
4
|
1
|
3
|
4
|
9
|
32
|
9
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part1 QD(Median Exposure of 1.38months)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part1 QD(Median Exposure of 1.38months)
NOT COMPLETED
|
3
|
4
|
1
|
3
|
4
|
8
|
32
|
9
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part1 BID(Median Exposure of 1.41months)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
10
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part1 BID(Median Exposure of 1.41months)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part1 BID(Median Exposure of 1.41months)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
10
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy-Period(P)1, Week1(Day1 to Day3)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
|
Substudy-Period(P)1, Week1(Day1 to Day3)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
|
Substudy-Period(P)1, Week1(Day1 to Day3)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy-P2, Week1Day3 to Week2Day1
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
|
Substudy-P2, Week1Day3 to Week2Day1
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
|
Substudy-P2, Week1Day3 to Week2Day1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy-P3, Week2Day1 to Week2Day3
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
|
Substudy-P3, Week2Day1 to Week2Day3
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
|
Substudy-P3, Week2Day1 to Week2Day3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy-P4,Maximum Exposure of 5.5month
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
|
Substudy-P4,Maximum Exposure of 5.5month
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy-P4,Maximum Exposure of 5.5month
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
|
Part2(Median Exposure of 1.41 Months)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
12
|
14
|
23
|
19
|
21
|
13
|
0
|
0
|
|
Part2(Median Exposure of 1.41 Months)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part2(Median Exposure of 1.41 Months)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
12
|
14
|
22
|
19
|
21
|
13
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1: GSK525762 2 mg QD
Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.
|
Part 1: GSK525762 4 mg QD
Participants were administered once daily oral dose of 4 mg GSK525762
|
Part 1: GSK525762 8 mg QD
Participants were administered once daily oral dose of 8 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 20 mg BID
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 2: Participants With NMC
Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762.
|
Part 2: Participants With SCLC
Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762
|
Part 2: Participants With CRPC
Participants with Castrate-Resistant Prostate Cancer (CRPR) were administered continuous once daily oral dose of 75 mg GSK525762
|
Part 2: Participants With TNBC
Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762.
|
Part 2: Participants With ER+BC
Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762
|
Part 2: Participants With GIST
Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762.
|
80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes
Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.
|
80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes
Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part1 QD(Median Exposure of 1.38months)
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part1 QD(Median Exposure of 1.38months)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part1 QD(Median Exposure of 1.38months)
Site closed
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part1 QD(Median Exposure of 1.38months)
Death
|
2
|
4
|
1
|
3
|
4
|
7
|
30
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part1 BID(Median Exposure of 1.41months)
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
9
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part1 BID(Median Exposure of 1.41months)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part1 BID(Median Exposure of 1.41months)
Site closed
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part1 BID(Median Exposure of 1.41months)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy-P4,Maximum Exposure of 5.5month
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Substudy-P4,Maximum Exposure of 5.5month
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
4
|
|
Part2(Median Exposure of 1.41 Months)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part2(Median Exposure of 1.41 Months)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Part2(Median Exposure of 1.41 Months)
Site closed
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
1
|
1
|
3
|
8
|
0
|
0
|
|
Part2(Median Exposure of 1.41 Months)
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
12
|
21
|
16
|
17
|
5
|
0
|
0
|
|
Part2(Median Exposure of 1.41 Months)
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects With NUT Midline Carcinoma (NMC) and Other Cancers
Baseline characteristics by cohort
| Measure |
Part 1: GSK525762 4 mg QD
n=4 Participants
Participants were administered once daily oral dose of 4 mg GSK525762
|
Part 1: GSK525762 8 mg QD
n=1 Participants
Participants were administered once daily oral dose of 8 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=3 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=4 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=9 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=32 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
n=9 Participants
Participants were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 20 mg BID
n=4 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
All Participants in Besylate Substudy
n=10 Participants
All participants who entered besylate sub-study and received 80 mg amor free-base tablet along with 6 mg stable iso in solution in fasted state; 80 mg bes tablet along with 6 mg stable iso in solution in fasted state, 30 mg bes tablet along with 6 mg stable iso in solution in fasted state and 80 mg bes tablet with FDA recommended high fat breakfast in one of the treatment periods were included.
|
Part 2: Participants With NMC
n=12 Participants
Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762.
|
Part 2: Participants With SCLC
n=14 Participants
Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762
|
Part 2: Participants With CRPC
n=23 Participants
Participants with Castrate-Resistant Prostate Cancer (CRPR) were administered continuous once daily oral dose of 75 mg GSK525762
|
Part 1: GSK525762 2 mg QD
n=3 Participants
Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.
|
Part 2: Participants With TNBC
n=19 Participants
Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762.
|
Part 2: Participants With ER+BC
n=21 Participants
Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762
|
Part 2: Participants With GIST
n=13 Participants
Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762.
|
Total
n=196 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
23 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
7 Participants
n=44 Participants
|
91 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
Central/South Asian Heritage (Her)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
3 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
Japanese Her/East Asian Her/South East Asian Her
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
9 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
12 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
8 Participants
n=36 Participants
|
23 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
15 Participants
n=135 Participants
|
18 Participants
n=136 Participants
|
10 Participants
n=44 Participants
|
163 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
8 Participants
n=667 Participants
|
|
Age, Continuous
|
47.0 Years
STANDARD_DEVIATION 19.44 • n=5 Participants
|
39.0 Years
STANDARD_DEVIATION NA • n=7 Participants
|
53.7 Years
STANDARD_DEVIATION 4.19 • n=5 Participants
|
49.3 Years
STANDARD_DEVIATION 23.27 • n=4 Participants
|
46.7 Years
STANDARD_DEVIATION 17.06 • n=21 Participants
|
51.5 Years
STANDARD_DEVIATION 16.82 • n=8 Participants
|
58.3 Years
STANDARD_DEVIATION 19.92 • n=8 Participants
|
66.5 Years
STANDARD_DEVIATION 6.45 • n=24 Participants
|
63.5 Years
STANDARD_DEVIATION 8.42 • n=42 Participants
|
60.4 Years
STANDARD_DEVIATION 4.83 • n=42 Participants
|
55.2 Years
STANDARD_DEVIATION 9.96 • n=42 Participants
|
42.9 Years
STANDARD_DEVIATION 18.05 • n=42 Participants
|
58.3 Years
STANDARD_DEVIATION 11.04 • n=36 Participants
|
63.8 Years
STANDARD_DEVIATION 6.11 • n=36 Participants
|
40.0 Years
STANDARD_DEVIATION 15.77 • n=24 Participants
|
50.8 Years
STANDARD_DEVIATION 8.66 • n=135 Participants
|
59.7 Years
STANDARD_DEVIATION 10.34 • n=136 Participants
|
61.0 Years
STANDARD_DEVIATION 13.23 • n=44 Participants
|
55.4 Years
STANDARD_DEVIATION 14.37 • n=667 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
9 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
19 Participants
n=135 Participants
|
21 Participants
n=136 Participants
|
6 Participants
n=44 Participants
|
105 Participants
n=667 Participants
|
PRIMARY outcome
Timeframe: Median of 1.38 months of drug exposurePopulation: All Treated Population
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment. All Treated Population comprised of all participants who received at least one dose of study treatment.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=3 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=4 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=1 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=3 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=4 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=9 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=32 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
n=9 Participants
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 QD
Any AE
|
3 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
9 Participants
|
31 Participants
|
9 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 QD
Any SAE
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
21 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Median of 1.41 months of drug exposurePopulation: All Treated Population
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=4 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With AEs and SAEs-Part 1 BID
Any AE
|
4 Participants
|
10 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With AEs and SAEs-Part 1 BID
Any SAE
|
0 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Median of 1.41 months of drug exposurePopulation: All Treated Population
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=12 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=14 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=23 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=19 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=21 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=13 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With AEs and SAEs-Part 2
Any AE
|
11 Participants
|
14 Participants
|
23 Participants
|
19 Participants
|
21 Participants
|
13 Participants
|
—
|
—
|
|
Number of Participants With AEs and SAEs-Part 2
Any SAE
|
6 Participants
|
9 Participants
|
16 Participants
|
11 Participants
|
15 Participants
|
8 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Median of 1.38 months of drug exposurePopulation: All Treated Population
The number of participants who had any dose reductions or delays is presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=3 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=4 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=1 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=3 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=4 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=9 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=32 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
n=9 Participants
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Reductions or Delays-Part 1 QD
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
8 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Median of 1.41 months of drug exposurePopulation: All Treated Population
The number of participants who had any dose reductions or delays is presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=4 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Reductions or Delays-Part 1 BID
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Median of 1.41 months of drug exposurePopulation: All Treated Population
The number of participants who had any dose reductions or delays is presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=12 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=14 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=23 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=19 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=21 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=13 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Reductions or Delays-Part 2
|
7 Participants
|
4 Participants
|
11 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Median of 1.87 months of drug exposurePopulation: All Treated Population
The number of participants who had any dose reductions or delays is presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=5 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Reductions or Delays-Besylate Sub-study
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Median of 1.38 months of drug exposurePopulation: All Treated Population
Number of participants withdrawn due to toxicities is presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=3 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=4 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=1 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=3 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=4 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=9 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=32 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
n=9 Participants
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Withdrawn Due to Toxicities-Part 1 QD
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
7 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Median of 1.41 months of drug exposurePopulation: All Treated Population
Number of participants withdrawn due to toxicities is presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=4 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Withdrawn Due to Toxicities-Part 1 BID
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Median of 1.41 months of drug exposurePopulation: All Treated Population
Number of participants withdrawn due to toxicities is presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=12 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=14 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=23 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=19 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=21 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=13 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Withdrawn Due to Toxicities-Part 2
|
1 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Median of 1.87 months of drug exposurePopulation: All Treated Population
Number of participants withdrawn due to toxicities is presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=5 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Withdrawn Due to Toxicities-Besylate Sub-study
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposurePopulation: All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
Blood samples were collected for the analysis of: glucose, albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), amylase, aspartate aminotransferase (AST), direct bilirubin (Dir bil), bilirubin, N-Terminal proB-type natriuretic peptide (NT-BNP), calcium, cholesterol, creatine kinase (CK), chloride, carbon dioxide (CO2), creatinine, gamma glutamyl transferase (GGT), high and low density lipoprotein (HDL and LDL), insulin, potassium, lactate dehydrogenase (LDH), lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides, troponin I and T, urate and urea. Grading was done according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on first study treatment dose date. Data for worst case post-Baseline is presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=3 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=4 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=1 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=3 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=4 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=9 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=32 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
n=9 Participants
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Glucose; Any grade increase; n=2,4,1,3,4,9,32,9
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
7 Participants
|
24 Participants
|
8 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Glucose; Increase to Grade 3; n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Glucose; Increase to Grade 4; n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Albumin; Any grade increase; n=2,4,1,3,4,9,32,9
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
12 Participants
|
1 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Albumin; Increase to Grade 3; n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Albumin; Increase to Grade 4; n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
ALP; Any grade increase; n=2,4,1,3,4,9,31,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
ALP; Increase to Grade 3; n=2,4,1,3,4,9,31,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
ALP; Increase to Grade 4; n=2,4,1,3,4,9,31,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
ALT; Any grade increase; n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
9 Participants
|
2 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
ALT; Increase to Grade 3; n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
ALT; Increase to Grade 4; n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Amylase; Any grade increase; n=2,4,1,3,4,9,32,9
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
10 Participants
|
1 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
NT-BNP; Increase to Grade 3; n=2,4,1,3,4,9,30,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
NT-BNP; Increase to Grade 4; n=2,4,1,3,4,9,30,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Calcium; Increase to Grade 3; n=2,4,1,3,4,9,32,9
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Calcium; Increase to Grade 4; n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Cholesterol;Any grade increase;n=2,4,1,3,4,7,29,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
11 Participants
|
1 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Cholesterol;Increase to Grade 3;n=2,4,1,3,4,7,29,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Cholesterol;Increase to Grade 4;n=2,4,1,3,4,7,29,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
CK;Any grade increase;n=3,4,1,3,4,9,31,9
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
11 Participants
|
5 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
CK; Increase to Grade 3; n=3, 4, 1, 3, 4, 9, 31, 9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
CK; Increase to Grade 4; n=3, 4, 1, 3, 4, 9, 31, 9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Chloride; Any grade increase; n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Chloride; Increase to Grade 3;n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Chloride;Increase to Grade 4;n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
CO2; Any grade increase; n=2, 4, 1, 3, 4, 9, 32, 9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
CO2; Increase to Grade 3; n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
CO2; Increase to Grade 4; n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Creatinine;Any grade increase;n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Creatinine;Increase to Grade 3;n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Creatinine;Increase to Grade 4;n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
GGT; Any grade increase; n=2, 4, 1, 3, 4, 9, 31, 7
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
11 Participants
|
1 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
GGT;Increase to Grade 3; n=2,4,1,3,4,9,31,7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
GGT; Increase to Grade 4; n=2,4,1,3,4,9,31,7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
HDL; Any grade increase; n=2, 4, 1, 3, 4, 7, 28, 9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
HDL; Increase to Grade 3; n=2,4,1,3,4,7,28,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
HDL; Increase to Grade 4; n=2,4,1,3,4,7,28,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Insulin; Any grade increase; n=2,4,1,3,4,9,31,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Insulin; Increase to Grade 3; n=2,4,1,3,4,9,31,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Insulin; Increase to Grade 4; n=2,4,1,3,4,9,31,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Potassium;Any grade increase;n=3,4,1,3,4,9,32,9
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
13 Participants
|
3 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Potassium;Increase to Grade 3;n=3,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Potassium;Increase to Grade 4;n=3,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
LDH; Any grade increase; n=0, 0, 0, 0, 0, 1, 0, 0
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
LDH; Increase to Grade 3; n=0, 0, 0, 0, 0, 1, 0, 0
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
LDL; Any grade increase; n=2, 4, 1, 3, 4, 7, 28, 8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Urea; Increase to Grade 4; n=2,4,1,3,4,9,31,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Amylase; Increase to Grade 3; n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Amylase; Increase to Grade 4; n=2,4,1,3,4,9,32,9
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
AST; Increase to Grade 3; n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
AST; Increase to Grade 4; n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Dir bil; Any grade increase; n=2,4,1,3,4,9,30,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Dir bil; Increase to Grade 3; n=2,4,1,3,4,9,30,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Dir bil; Increase to Grade 4; n=2,4,1,3,4,9,30,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Bilirubin; Any grade increase; n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
15 Participants
|
8 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Bilirubin; Increase to Grade 3; n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Bilirubin; Increase to Grade 4; n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
NT-BNP; Any grade increase; n=2,4,1,3,4,9,30,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Calcium; Any grade increase; n=2,4,1,3,4,9,32,9
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
17 Participants
|
3 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Lipase;Any grade increase; n=2,4,1,3,4,9,31,9
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
8 Participants
|
2 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Lipase;Increase to Grade 3; n=2,4,1,3,4,9,31,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Lipase;Increase to Grade 4; n=2,4,1,3,4,9,31,9
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Magnesium;Any grade increase;n=3,4,1,3,4,9,32,9
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
9 Participants
|
2 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Magnesium;Increase to Grade 3;n=3,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Magnesium;Increase to Grade 4;n=3,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Protein;Any grade increase; n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Protein;Increase to Grade 3; n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Protein;Increase to Grade 4; n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Sodium;Any grade increase; n=3,4,1,3,4,9,32,9
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
16 Participants
|
4 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Sodium;Increase to Grade 3; n=3,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Sodium;Increase to Grade 4; n=3,4,1,3,4,9,32,9
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Thyroxine;Any grade increase;n=2,4,1,3,4,7,29,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Thyroxine;Increase to Grade 3; n=2,4,1,3,4,7,29,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Thyroxine;Increase to Grade 4; n=2,4,1,3,4,7,29,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Testosterone;Any grade increase;n=1,0,0,0,3,3,14,7
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Testosterone;Increase to Grade3;n=1,0,0,0,3,3,14,7
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Testosterone;Increase to Grade4;n=1,0,0,0,3,3,14,7
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Triglyc;Any grade increase;n=2,4,1,3,4,7,29,9
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
17 Participants
|
6 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Triglyc;Increase to Grade 3;n=2,4,1,3,4,7,29,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Triglyc;Increase to Grade 4;n=2,4,1,3,4,7,29,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Troponin I;Any grade increase;n=0,0,0,0, 2,5,24,5
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Troponin I;Increase to Grade 3;n=0,0,0,0,2,5,24,5
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Troponin I;Increase to Grade 4; n=0,0,0,0,2,5,24,5
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Troponin T;Any grade increase;n=3,4,1,3,4,9,31,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Troponin T;Increase to Grade 3; n=3,4,1,3,4,9,31,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Troponin T;Increase to Grade 4; n=3,4,1,3,4,9,31,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Urate;Any grade increase; n=2,4,1,3,4,9,32,9
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Urate; Increase to Grade 3; n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Urate; Increase to Grade 4; n=2,4,1,3,4,9,32,9
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Urea; Any grade increase; n=2,4,1,3,4,9,31,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Urea; Increase to Grade 3; n=2,4,1,3,4,9,31,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
LDH; Increase to Grade 4; n=0, 0, 0, 0, 0, 1, 0, 0
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
LDL;Increase to Grade 3; n=2,4,1,3,4,7,28,8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
LDL;Increase to Grade 4; n=2,4,1,3,4,7,28,8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
AST; Any grade increase; n=2,4,1,3,4,9,32,9
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
14 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposurePopulation: All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
Blood samples were collected for the analysis of clinical chemistry parameters: glucose, albumin, ALP, ALT, amylase, AST, Dir bil, bilirubin, NT-BNP, calcium, cholesterol, CK, chloride, CO2, creatinine, GGT, HDL and LDL cholesterol, insulin, potassium, LDH, lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides, troponin I and T, urate and urea. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post-Baseline is presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=4 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Urea; Increase to Grade 4; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Cholesterol; Any grade increase; n=2, 9, 5
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Chloride; Increase to Grade 3; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Glucose; Any grade increase; n=4, 10, 5
|
1 Participants
|
9 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Glucose; Increase to Grade 3; n=4, 10, 5
|
1 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Glucose; Increase to Grade 4; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Albumin; Any grade increase; n=4, 10, 5
|
0 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Albumin; Increase to Grade 3; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Albumin; Increase to Grade 4; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
ALP; Any grade increase; n=4, 10, 5
|
0 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
ALP; Increase to Grade 3; n=4, 10, 5
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
ALP; Increase to Grade 4; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
ALT; Any grade increase; n=4, 10, 5
|
0 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
ALT; Increase to Grade 3; n=4, 10, 5
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
ALT; Increase to Grade 4; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Amylase; Any grade increase; n=4, 10, 5
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Amylase; Increase to Grade 3; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Amylase; Increase to Grade 4; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
AST; Any grade increase; n=4, 10, 5
|
2 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
AST; Increase to Grade 3; n=4, 10, 5
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
AST; Increase to Grade 4; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Dir bil; Any grade increase; n=4, 9, 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Dir bil; Increase to Grade 3; n=4, 9, 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Dir bil; Increase to Grade 4; n=4, 9, 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Bilirubin; Any grade increase; n=4, 10, 5
|
1 Participants
|
7 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Bilirubin; Increase to Grade 3; n=4, 10, 5
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Bilirubin; Increase to Grade 4; n=4, 10, 5
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
NT-BNP; Any grade increase; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
NT-BNP; Increase to Grade 3; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
NT-BNP; Increase to Grade 4; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Calcium; Any grade increase; n=4, 10, 5
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Calcium; Increase to Grade 3; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Calcium; Increase to Grade 4; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Cholesterol; Increase to Grade 3; n=2, 9, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Cholesterol; Increase to Grade 4; n=2, 9, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
CK; Any grade increase; n=4, 10, 5
|
0 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
CK; Increase to Grade 3; n=n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Chloride; Increase to Grade 4; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
CK; Increase to Grade 4; n=n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Chloride; Any grade increase; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
CO2; Any grade increase; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
CO2; Increase to Grade 3; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
CO2; Increase to Grade 4; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
GGT; Any grade increase; n=4, 10, 5
|
0 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Creatinine; Any grade increase; n=4, 10, 5
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Creatinine; Increase to Grade 3; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Creatinine; Increase to Grade 4; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
GGT; Increase to Grade 3; n=4, 10, 5
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
GGT; Increase to Grade 4; n=4, 10, 5
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
HDL; Any grade increase; n=2, 9, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
HDL; Increase to Grade 3; n=2, 9, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
HDL; Increase to Grade 4; n=2, 9, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Insulin; Any grade increase; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Insulin; Increase to Grade 3; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Insulin; Increase to Grade 4; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Potassium; Any grade increase; n=4, 10, 5
|
1 Participants
|
5 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Potassium; Increase to Grade 3; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Potassium; Increase to Grade 4; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
LDL; Any grade increase; n=2, 9, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
LDL; Increase to Grade 3; n=2, 9, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
LDL; Increase to Grade 4; n=2, 9, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Lipase; Any grade increase; n=4, 10, 5
|
0 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Lipase; Increase to Grade 3; n=4, 10, 5
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Lipase; Increase to Grade 4; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Magnesium; Any grade increase; n=4, 10, 5
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Magnesium; Increase to Grade 3; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Magnesium; Increase to Grade 4; n=4, 10, 5
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Protein; Any grade increase; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Protein; Increase to Grade 3; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Protein; Increase to Grade 4; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Sodium; Any grade increase; n=4, 10, 5
|
0 Participants
|
7 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Sodium; Increase to Grade 3; n=4, 10, 5
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Sodium; Increase to Grade 4; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Thyroxine; Any grade increase; n=3, 9, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Thyroxine; Increase to Grade 3; n=3, 9, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Thyroxine; Increase to Grade 4; n=3, 9, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Testosterone; Any grade increase; n=1, 4, 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Testosterone; Increase to Grade 3; n=1, 4, 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Testosterone; Increase to Grade 4; n=1, 4, 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Triglycerides; Any grade increase; n=2, 9, 5
|
0 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Triglycerides; Increase to Grade 3; n=2, 9, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Triglycerides; Increase to Grade 4; n=2, 9, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Troponin I; Any grade increase; n=3, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Troponin I; Increase to Grade 3; n=3, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Troponin I; Increase to Grade 4; n=3, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Troponin T; Any grade increase; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Troponin T; Increase to Grade 3; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Troponin T; Increase to Grade 4; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Urate; Any grade increase; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Urate; Increase to Grade 3; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Urate; Increase to Grade 4; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Urea; Any grade increase; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Urea; Increase to Grade 3; n=4, 10, 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposurePopulation: All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
Blood samples were collected for the analysis of clinical chemistry parameters: glucose, albumin, ALP, ALT, amylase, AST, Dir bil, bilirubin, NT-BNP, calcium, cholesterol, CK, chloride, CO2, creatinine, GGT, HDL and LDL cholesterol, insulin, potassium, LDH, lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides (triglyc), troponin I and T, urate and urea. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post-Baseline is presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=12 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=14 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=23 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=19 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=21 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=13 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
CO2; Increase to Grade 4; n=11,12,23,19,21,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Creatinine;Any grade increase;n=11,14,23,19,21,12
|
3 Participants
|
4 Participants
|
9 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Protein; Increase to Grade 3;n=11,13,23,19,21,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Lipase; Any grade increase; n=11,12,22,19,20,12
|
3 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Lipase; Increase to Grade 3;n=11,12,22,19,20,12
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Lipase; Increase to Grade 4;n=11,12,22,19,20,12
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Magnesium; Any grade increase; n=11,12,22,19,21,12
|
2 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Magnesium; Increase to Grade 3;n=11,12,22,19,21,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Magnesium; Increase to Grade4;n=11,12,22,19,21,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Protein; Increase to Grade 4;n=11,13,23,19,21,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Sodium; Any grade increase; n=11, 14,23,19,21,12
|
5 Participants
|
5 Participants
|
8 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Sodium; Increase to Grade 3; n=11, 14,23,19,21,12
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Sodium; Increase to Grade 4; n=11, 14,23,19,21,12
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Thyroxine; Any grade increase;n=7,7,20,15,18,8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Thyroxine; Increase to Grade3;n=7,7,20,15,18,8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Thyroxine; Increase to Grade4;n=7,7,20,15,18,8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Testosterone; Any grade increase; n=4,3,18,0,1,5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Testosterone; Increase to Grade3; n=4,3,18,0,1,5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Triglyc;Increase to Grade4;n=10,12,22,19,20,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Troponin I; Any grade increase; n=7,6,15,15,14,7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Troponin I; Increase to Grade 3; n=7,6,15,15,14,7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Troponin I; Increase to Grade 4; n=7,6,15,15,14,7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Troponin T;Increase to Grade4;n=11,12,22,19,20,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Troponin T;Any grade increase;n=11,12,22,19,20,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Troponin T;Increase to Grade3;n=11,12,22,19,20,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Urate; Any grade increase; n=11,12,22,19,20,12
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Urate; Increase to Grade 3; n=11,12,22,19,20,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Urate; Increase to Grade 4; n=11,12,22,19,20,12
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Glucose; Any grade increase; n=11,13,23,19,21,12
|
10 Participants
|
10 Participants
|
20 Participants
|
16 Participants
|
18 Participants
|
9 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
CK; Increase to Grade 4; n=9,9,21,17,18,11
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Chloride; Any grade increase; n=11,13,23,19,21,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
CO2; Increase to Grade 3; n=11,12,23,19,21,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Creatinine;Increase to Grade3;n=11,14,23,19,21,12
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
GGT; Any grade increase; n=11,13,22,19,20,12
|
0 Participants
|
3 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
GGT; Increase to Grade 3; n=11,13,22,19,20,12
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
GGT; Increase to Grade 4; n=11,13,22,19,20,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
HDL; Any grade increase; n=10,10,22,19,19,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Creatinine;Increase to Grade4;n=11,14,23,19,21,12
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
HDL; Increase to Grade 3; n=10,10,22,19,19,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
LDL; Increase to Grade 3; n=10,10,22,19,19,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
HDL; Increase to Grade 4;n=10,10,22,19,19,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Insulin; Any grade increase; n=11,12,22,19,20,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Insulin; Increase to Grade 3; n=11,12,22,19,20,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Insulin; Increase to Grade 4; n=11,12,22,19,20,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Potassium; Any grade increase; n=11,14,23,19,21,12
|
6 Participants
|
4 Participants
|
10 Participants
|
5 Participants
|
7 Participants
|
7 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Potassium;Increase to Grade3;n=11,14,23,19,21,12
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Potassium;Increase to Grade4;n=11,14,23,19,21,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
LDL; Increase to Grade 4;n=10,10,22,19,19,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Protein; Any grade increase; n=11,13,23,19,21,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
LDL; Any grade increase; n=10,10,22,19,19,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Testosterone; Increase to Grade4; n=4,3,18,0,1,5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Triglyc;Any grade increase;n=10,12,22,19,20,12
|
7 Participants
|
7 Participants
|
15 Participants
|
10 Participants
|
11 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Triglyc;Increase to Grade3;n=10,12,22,19,20,12
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Urea; Any grade increase; n=11,14,23,17,17,11
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Urea; Increase to Grade 3; n=11,14,23,17,17,11
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Urea; Increase to Grade 4;n=11,14,23,17,17,11
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Cholesterol;Increase to Grade3;n=10,12,22,19,20,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Cholesterol;Increase to Grade4;n=10,12,22,19,20,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
CK; Any grade increase; n=9,9,21,17,18,11
|
3 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
7 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
CK; Increase to Grade 3; n=9,9,21,17,18,11
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Amylase; Any grade increase; n=11,12,22,19,20,12
|
5 Participants
|
5 Participants
|
9 Participants
|
5 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Chloride; Increase to Grade 3; n=11,13,23,19,21,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Chloride; Increase to Grade 4; n=11,13,23,19,21,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
CO2; Any grade increase; n=11,12,23,19,21,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Glucose; Increase to Grade 3; n=11,13,23,19,21,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Glucose; Increase to Grade 4; n=11,13,23,19,21,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Albumin; Any grade increase; n=11,13,23,19,21,12
|
5 Participants
|
6 Participants
|
9 Participants
|
8 Participants
|
7 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Albumin; Increase to Grade 3; n=11,13,23,19,21,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Albumin; Increase to Grade 4; n=11,13,23,19,21,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
ALP; Any grade increase; n=11,13,23,19,21,12
|
3 Participants
|
1 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
ALP; Increase to Grade 3; n=11,13,23,19,21,12
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
ALP; Increase to Grade 4; n=11,13,23,19,21,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
ALT; Any grade increase; n=11,14,23,19,21,12
|
3 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
12 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
ALT; Increase to Grade 3; n=11,14,23,19,21,12
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
ALT; Increase to Grade 4; n=11,14,23,19,21,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Amylase; Increase to Grade 3; n=11,12,22,19,20,12
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Amylase; Increase to Grade 4; n=11,12,22,19,20,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
AST; Any grade increase; n=11,13,23,19,21,12
|
3 Participants
|
5 Participants
|
10 Participants
|
8 Participants
|
14 Participants
|
6 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
AST; Increase to Grade 3; n=11,13,23,19,21,12
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
AST; Increase to Grade 4; n=11,13,23,19,21,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Dir bil; Any grade increase; n=11,13,23,19,20,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Dir bil; Increase to Grade 3; n=11,13,23,19,20,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Dir bil; Increase to Grade 4; n=11,13,23,19,20,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Bilirubin;Any grade increase;n=11,14,23,19,21,12
|
8 Participants
|
10 Participants
|
13 Participants
|
6 Participants
|
13 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Bilirubin;Increase to Grade 3; n=11,14,23,19,21,12
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Bilirubin;Increase to Grade 4; n=11,14,23,19,21,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
NT-BNP; Any grade increase; n=11,12,22,17,15,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
NT-BNP; Increase to Grade 3; n=11,12,22,17,15,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
NT-BNP; Increase to Grade 4; n=11,12,22,17,15,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Calcium; Any grade increase; n=11,13,23,19,21,12
|
6 Participants
|
3 Participants
|
8 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Calcium; Increase to Grade 3; n=11,13,23,19,21,12
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Calcium; Increase to Grade 4; n=11,13,23,19,21,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Cholesterol;Any grade increase;n=10,12,22,19,20,12
|
5 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
9 Participants
|
5 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposurePopulation: All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
Blood samples were collected for the analysis of clinical chemistry parameters: glucose, albumin, ALP, ALT, amylase, AST, Dir bil, bilirubin, NT-BNP, calcium, cholesterol, CK, chloride, CO2, creatinine, GGT, HDL and LDL cholesterol, insulin, potassium, LDH, lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides, troponin I and T, urate and urea. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=5 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Glucose; Increase to Grade 3; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Glucose; Increase to Grade 4; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
ALT; Increase to Grade 4; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Amylase; Any grade increase; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Amylase; Increase to Grade 3; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Amylase; Increase to Grade 4; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
AST; Any grade increase; n=5,5
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
AST; Increase to Grade 3; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Dir bil; Increase to Grade 4; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Bilirubin; Any grade increase; n=5,5
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
HDL; Increase to Grade 4; n=5,3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Triglycerides; Increase to Grade 3; n=5,3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Triglycerides; Increase to Grade 4; n=5,3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Troponin T; Increase to Grade 4; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Albumin; Any grade increase; n=5,5
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Albumin; Increase to Grade 4; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
ALP; Any grade increase; n=5,5
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Albumin; Increase to Grade 3; n=5,5
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
ALP; Increase to Grade 3; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
ALP; Increase to Grade 4; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
ALT; Any grade increase; n=5,5
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
ALT; Increase to Grade 3; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
AST; Increase to Grade 4; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Dir bil; Any grade increase; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Dir bil; Increase to Grade 3; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Glucose; Any grade increase; n=5,5
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Bilirubin; Increase to Grade 3; n=5,5
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
CO2; Any grade increase; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Bilirubin; Increase to Grade 4; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
NT-BNP; Any grade increase; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
NT-BNP; Increase to Grade 3; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
NT-BNP; Increase to Grade 4; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Calcium; Any grade increase; n=5,5
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Calcium; Increase to Grade 3; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Calcium; Increase to Grade 4; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Cholesterol; Any grade increase; n=5,3
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Cholesterol; Increase to Grade 3; n=5,3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Cholesterol; Increase to Grade 4; n=5,3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
CK; Any grade increase; n=5,5
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
CK; Increase to Grade 3; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
CK; Increase to Grade 4; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Chloride; Any grade increase; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Chloride; Increase to Grade 3; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Chloride; Increase to Grade 4; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
CO2; Increase to Grade 3; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
CO2; Increase to Grade 4; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Creatinine; Any grade increase; n=5,5
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Creatinine; Increase to Grade 3; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Creatinine; Increase to Grade 4; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
GGT; Any grade increase; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
GGT; Increase to Grade 3; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
GGT; Increase to Grade 4; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
HDL; Any grade increase; n=5,3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
HDL; Increase to Grade 3; n=5,3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Insulin; Any grade increase; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Insulin; Increase to Grade 3; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Insulin; Increase to Grade 4; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Potassium; Any grade increase; n=5,5
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Potassium; Increase to Grade 3; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Potassium; Increase to Grade 4; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
LDL; Any grade increase; n=5,3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
LDL; Increase to Grade 3; n=5,3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
LDL; Increase to Grade 4; n=5,3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Lipase; Any grade increase; n=5,4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Lipase; Increase to Grade 3; n=5,4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Lipase; Increase to Grade 4;n=5,4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Magnesium; Any grade increase; n=5,5
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Magnesium; Increase to Grade 3; n=5,5
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Magnesium; Increase to Grade 4; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Protein; Any grade increase; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Protein; Increase to Grade 3; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Protein; Increase to Grade 4; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Sodium; Any grade increase; n=5,5
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Sodium; Increase to Grade 3; n=5,5
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Sodium; Increase to Grade 4; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Thyroxine; Any grade increase; n=5,3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Thyroxine; Increase to Grade 3; n=5,3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Thyroxine; Increase to Grade 4; n=5,3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Testosterone; Any grade increase; n=2,1
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Testosterone; Increase to Grade 3; n=2,1
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Testosterone; Increase to Grade 4; n=2,1
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Triglycerides; Any grade increase; n=5,3
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Troponin I; Any grade increase; n=1,0
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Troponin I; Increase to Grade 3; n=1,0
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Troponin I; Increase to Grade 4; n=1,0
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Troponin T; Any grade increase; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Troponin T; Increase to Grade 3; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Urate; Any grade increase; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Urate; Increase to Grade 3; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Urate; Increase to Grade 4; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Urea; Any grade increase; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Urea; Increase to Grade 3; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Urea; Increase to Grade 4; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposurePopulation: All Treated Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected for the analysis of hematology parameters: activated partial thromboplastin time (aPTT), platelet count, red blood cell count (RBC), white blood cell count (WBC), prothrombin international normalized ratio (INR), prothrombin time (PT), fibrinogen (Fib), hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=2 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=4 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=1 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=3 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=4 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=9 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=32 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
n=9 Participants
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
INR; Any grade increase
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
21 Participants
|
2 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
Lymphocytes;Increase to Grade3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
8 Participants
|
1 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
Platelets;Any grade increase
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
26 Participants
|
8 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
Hemoglobin;Any grade increase
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
21 Participants
|
7 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
Hemoglobin;Increase to Grade 3; n=2,4,1,3,4,9,32,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
9 Participants
|
1 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
Basophils;Any grade increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
Basophils;Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
Basophils;Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
Eosinophils;Any grade increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
Eosinophils;Increase to Grade3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
Eosinophils;Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
Hemoglobin;Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
INR;Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
INR; Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
Lymphocytes;Any grade increase
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
19 Participants
|
4 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
Lymphocytes;Increase to Grade4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
Monocytes;Any grade increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
Monocytes;Increase to Grade3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
00 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
Monocytes;Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
Neutrophils;Any grade increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
Neutrophils;Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
Neutrophils;Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
Platelets;Increase to Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
11 Participants
|
5 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
Platelets;Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
PT; Any grade increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
PT; Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
PT; Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
RBC; Any grade increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
RBC;Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
RBC;Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
WBC; Any grade increase
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
11 Participants
|
5 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
WBC; Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
WBC; Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
Fib; Any grade increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
Fib;Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
Fib;Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
aPTT; Any grade increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
14 Participants
|
2 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
aPTT; Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
aPTT; Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposurePopulation: All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
Blood samples were collected for the analysis of hematology parameters: aPTT, platelet count, RBC, WBC, INR, PT, Fib, hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=4 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
RBC; Increase to Grade 4; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
Neutrophils; Increase to Grade 3; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
Neutrophils; Increase to Grade 4; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
Platelets; Any grade increase; n=4,10,5
|
1 Participants
|
10 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
aPTT; Increase to Grade 4; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
Basophils; Any grade increase; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
Basophils; Increase to Grade 3; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
Basophils; Increase to Grade 4; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
Eosinophils; Any grade increase; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
Eosinophils; Increase to Grade3; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
Eosinophils; Increase to Grade4; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
Hemoglobin; Any grade increase; n=4,10,5
|
4 Participants
|
8 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
Hemoglobin; Increase to Grade 3; n=4,10,5
|
0 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
Hemoglobin; Increase to Grade 4; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
INR; Any grade increase; n=4,10,5
|
0 Participants
|
6 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
INR; Increase to Grade 3; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
INR; Increase to Grade 4; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
Lymphocytes; Any grade increase; n=4,10,5
|
2 Participants
|
8 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
Lymphocytes; Increase to Grade3; n=4,10,5
|
0 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
Lymphocytes; Increase to Grade4; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
Monocytes; Any grade increase; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
Monocytes;Increase to Grade3; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
Monocytes; Increase to Grade 4; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
Neutrophils; Any grade increase; n=4,10,5
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
Platelets; Increase to Grade 3; n=4,10,5
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
Platelets; Increase to Grade 4; n=4,10,5
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
PT; Any grade increase;n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
PT; Increase to Grade 3; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
PT; Increase to Grade 4; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
RBC; Any grade increase; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
RBC; Increase to Grade 3; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
WBC; Any grade increase; n=4,10,5
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
WBC; Increase to Grade 3; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
WBC; Increase to Grade 4; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
Fib; Any grade increase; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
Fib; Increase to Grade 3; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
Fib; Increase to Grade 4; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
aPTT; Any grade increase; n=4,10,5
|
0 Participants
|
5 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
aPTT; Increase to Grade 3; n=4,10,5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposurePopulation: All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
Blood samples were collected for the analysis of hematology parameters: aPTT, platelet count, RBC, WBC, INR, PT, Fib, hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=12 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=14 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=23 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=19 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=21 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=13 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
Eosinophils;Increase to Grade4;n=11,13,23,19,21,13
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
Lymphocytes;Increase to Grade4;n=11,13,23,19,21,13
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
PT; Any grade increase;n=10,10, 18, 17, 18, 12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
PT; Increase to Grade 3; n=10,10, 18, 17, 18, 12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
Fib; Increase to Grade 4; n=11, 11, 21, 17, 18, 12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
Lymphocytes;Increase to Grade3;n=11,13,23,19,21,13
|
2 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
Basophils; Any grade increase; n=11,13,23,19,21,13
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
Basophils; Increase to Grade3; n=11,13,23,19,21,13
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
Basophils; Increase to Grade4; n=11,13,23,19,21,13
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
Eosinophils;Any grade increase;n=11,13,23,19,21,13
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
Eosinophils;Increase to Grade3;n=11,13,23,19,21,13
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
Hemoglobin;Any grade increase;n=11,14,23,19,21,13
|
6 Participants
|
10 Participants
|
18 Participants
|
10 Participants
|
18 Participants
|
6 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
Hemoglobin;Increase to Grade3;n=11,14,23,19,21,13
|
3 Participants
|
2 Participants
|
9 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
Hemoglobin;Increase to Grade4;n=11,14, 23,19,21,13
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
INR; Any grade increase; n=11,12,21,17,18,12
|
8 Participants
|
6 Participants
|
13 Participants
|
8 Participants
|
11 Participants
|
7 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
INR; Increase to Grade3; n=11,12,21,17,18,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
INR; Increase to Grade4; n=11,12,21,17,18,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
Lymphocytes;Any grade increase;n=11,13,23,19,21,13
|
8 Participants
|
7 Participants
|
14 Participants
|
9 Participants
|
13 Participants
|
6 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
Monocytes; Any grade increase; n=11,13,23,19,21,13
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
Monocytes;Increase to Grade3; n=11,13,23,19,21,13
|
0 Participants
|
0 Participants
|
00 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
Monocytes; Increase to Grade4; n=11,13,23,19,21,13
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
Neutrophils;Any grade increase;n=11,14,23,19,21,13
|
4 Participants
|
4 Participants
|
8 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
Neutrophils;Increase to Grade3;n=11,14,23,19,21,13
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
Neutrophils;Increase to Grade4;n=11,14,23,19,21,13
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
Platelets; Any grade increase; n=11,14,23,19,21,13
|
7 Participants
|
12 Participants
|
20 Participants
|
17 Participants
|
18 Participants
|
7 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
Platelets; Increase to Grade3; n=11,14,23,19,21,13
|
4 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
Platelets; Increase to Grade4; n=11,14,23,19,21,13
|
2 Participants
|
3 Participants
|
8 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
PT; Increase to Grade 4; n=10,10, 18, 17, 18, 12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
RBC; Any grade increase; n=11, 13, 23, 19, 21, 13
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
RBC; Increase to Grade 3; n=11, 13, 23, 19, 21, 13
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
RBC; Increase to Grade 4; n=11, 13, 23, 19, 21, 13
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
WBC; Any grade increase; n=11, 14, 23, 19, 21, 13
|
7 Participants
|
5 Participants
|
9 Participants
|
5 Participants
|
6 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
WBC; Increase to Grade 3; n=11, 14, 23, 19, 21, 13
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
WBC; Increase to Grade 4; n=11, 14, 23, 19, 21, 13
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
Fib; Any grade increase; n=11, 11, 21, 17, 18, 12
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
Fib; Increase to Grade 3; n=11, 11, 21, 17, 18, 12
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
aPTT; Any grade increase; n=11,12,21,17,18,12
|
4 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
aPTT; Increase to Grade3; n=11,12,21, 17, 18, 12
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
aPTT; Increase to Grade4; n=11,12,21,17,18,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposurePopulation: All Treated Population
Blood samples were collected for the analysis of hematology parameters: aPTT, platelet count, RBC, WBC, INR, PT, Fib, hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=5 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
RBC; Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
Basophils; Any grade increase
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
Basophils; Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
Basophils; Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
Eosinophils; Any grade increase
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
Eosinophils; Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
Eosinophils; Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
Hemoglobin; Any grade increase
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
Hemoglobin; Increase to Grade 3
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
Hemoglobin; Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
INR; Any grade increase
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
INR; Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
INR; Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
Lymphocytes; Any grade increase
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
Lymphocytes; Increase to Grade 3
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
Lymphocytes; Increase to Grade 4
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
Monocytes; Any grade increase
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
Monocytes; Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
Monocytes; Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
Neutrophils; Any grade increase
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
Neutrophils; Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
Neutrophils; Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
Platelets; Any grade increase
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
Platelets; Increase to Grade 3
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
Platelets; Increase to Grade 4
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
PT; Any grade increase
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
PT; Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
PT; Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
RBC; Any grade increase
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
RBC; Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
WBC; Any grade increase
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
WBC; Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
WBC; Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
Fib; Any grade increase
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
Fib; Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
Fib; Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
aPTT; Any grade increase
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
aPTT; Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
aPTT; Increase to Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Week1 Day1) and Weeks 5, 9, 17, 25, 33, 41, 49 and discharge/progression (disc/prog)Population: All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
Urine samples were collected for the analysis of following urine parameters: potential of hydrogen (pH), glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=3 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=4 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=1 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=3 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=4 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=9 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=32 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
n=9 Participants
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Hyaline casts;Week 9; n=0,1,0, 0,0,1,5,3
|
—
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Glucose;Week 5; n=1,2,1,3,2,7,20,7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Glucose;Week 25; n=0,1,0,0,0,0,3,1
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Glucose;Disc/Prog; n=0, 1, 0,1,0,3,17,2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
pH;Week 5; n=1, 2, 1, 3,2,7,20,7
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
6 Participants
|
3 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Specific gravity;Week 33; n=0,1,0,0,0,0,2,0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Cellular casts; Week 9; n=0,0, 0, 0, 0,1,4,1
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Cellular casts; Week 17; n=0,0, 0, 0, 0,0,1,0
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Cellular casts; Disc/Prog; n=0,0,0,0,0,1,5,1
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Hyaline casts;Week 5; n=0,1,0,0,1,2,5,3
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Glucose;Week 9; n=1, 1, 0, 1,1,3,12,5
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Ketones;Week 5; n=1,2,1,3,2,7,20,7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Ketones;Week 9; n=1,1,0,1,1,3,12,5
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Occult blood;Week 5; n=1,2,1,3,2,7,17,7
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Occult blood;Week 9; n=1,1,0,1,1,3,11,5
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Occult blood;Week 17; n=0, 1,0,0,0,0,5,3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Occult blood;Week 25; n=0,1,0,0,0,0,3,1
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Occult blood;Week 33; n=0,1,0,0,0,0,2,0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Occult blood;Disc/Prog; n=0,1,0,1,0,3,17,2
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
pH;Week 9; n=1,1,0,1,1,3,12,5
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
8 Participants
|
2 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
pH;Week 25; n=0,1,0,0,0,0,3,1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
pH;Week 33; n=0,1,0,0,0,0,2,0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
pH;Disc/Prog; n=0,1,0,1,0,3,17,2
|
—
|
1 Participants
|
—
|
0 Participants
|
—
|
1 Participants
|
9 Participants
|
1 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Protein;Week 5; n=1, 2,1,3,2,7,20,7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
9 Participants
|
4 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Protein;Week 9; n=1,1,0,1,1,3,12,5
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Protein;Week 17; n=0,1,0,0,0,0,5,3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Protein;Week 25; n=0,1,0,0,0,0,3,1
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Protein;Disc/Prog; n=0,1,0,1,0,3,17,2
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Specific gravity;Week 5; n=1,2,1,3,2,7,20,7
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Specific gravity;Week 9; n=1,1,0,1,1,3,12,5
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Specific gravity;Week 17; n=0,1,0,0,0,0,5,3
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
4 Participants
|
2 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Specific gravity;Week 25; n=0,1,0,0,0,0,3,1
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Specific gravity;Disc/Prog; n=0,1,0,1,0,3,16,2
|
—
|
1 Participants
|
—
|
1 Participants
|
—
|
1 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Specific gravity;Week 41; n=0,0,0,0,0,0,1,0
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Specific gravity;Week 49; n=0,0,0,0,0,0,1,0
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Leukocytes;Week 5; n=1,2,1,2,2,6,11,6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Leukocytes;Week 9; n=1,1,0,1,1,1,6,4
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Leukocytes;Week 17; n=0,1,0,0,0,0,1,2
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Leukocytes;Disc/Prog; n=0,1,0,1,0,2,6,1
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
4 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Week1 Day1) and Weeks 5,9,17 and discharge/progressionPopulation: All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
Urine samples were collected for the analysis of following urine parameters: pH, glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=4 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
Glucose; disc/prog;n=0,6,1
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
Occult blood; Week 5;n=2,7,3
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
Occult blood; Week 9;n=0,4,2
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
Occult blood; disc/prog;n=0,6,1
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
pH; Week 5;n=2,7,3
|
2 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
pH; Week 9;n=0,4,2
|
—
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
Protein; Week 5;n=2,7,3
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
Glucose; Week 5;n=2,7,3
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
Glucose; Week 9;n=0,4,2
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
Glucose; Week 17;n=0,2,0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
Ketones; Week 5;n=2,7,3
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
Ketones; Week 17;n=0,2,0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
pH; Week 17;n=0,2,0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
pH; disc/prog;n=0,7,1
|
—
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
Protein; Week 9;n=0,4,2
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
Protein; Week 17;n=0,2,0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
Protein; disc/prog;n=0,7,1
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
Erythrocytes; Week 5;n=1,5,1
|
1 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
Erythrocytes; Week 9;n=0,1,1
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
Erythrocytes; Week 17;n=0,1,0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
Specific gravity; Week 5;n=2,7,3
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
Specific gravity; Week 9;n=0,4,2
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
Specific gravity; Week 17;n=0,2,0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
Specific gravity; disc/prog;n=0,7,1
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
Leukocytes; Week 5;n=1,5,1
|
0 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
Leukocytes; Week 9;n=0,1,1
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
Leukocytes; Week 17;n=0,1,0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Week1 Day1), Weeks 5,9,13,25,37, 49, 73, 85 and discharge/progressionPopulation: All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
Urine samples were collected for the analysis of following urine parameters: pH, glucose, protein, blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=12 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=14 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=23 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=19 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=21 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=13 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Granular cast;Week5;n=0,2,2,1,3,0
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Granular cast;disc/prog;n=1,2,6,3,4,0
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Hyaline cast;Week9;n=0,0,1,2,1,1
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Hyaline cast;disc/prog;n=1,2,6,3,4,0
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Glucose;Week 5;n=8,7,18,12,14,8
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Glucose;Week9;n=8,3,12,3,6,5
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Glucose;Week13;n=7,2,6,1,2,2
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Glucose;Week37;n=3,0,1,0,0,0
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Ketones;Week5;n=8,7,18,12,14,8
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Ketones;Week9;n=8,3,12,3,6,5
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Ketones;disc/prog;n=3,6,16,12,12,5
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Occult blood;Week5;n=8,7,18,12,14,8
|
1 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
pH;Week13;n=7,2,6,1,2,2
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
pH;Week25;n=2,0,3,0,0,0
|
1 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
pH;Week37;n=3,0,1,0,0,0
|
3 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
pH;disc/prog;n=3,6,16,12,12,5
|
1 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Erythrocytes;disc/prog;n=1,2,6,3,4,2
|
0 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Hyaline cast;Week5;n=1,2,2,2,4,0
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Hyaline cast;Week13;n=1,1,0,0,0,0
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Glucose;Week49;n=1,0,1,0,0,0
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Glucose;Week73;n=1,0,0,0,0,0
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Glucose;Week85;n=1,0,0,0,0,0
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Glucose;disc/prog;n=3,6,16,12,12,5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Occult blood;Week9;n=8,3,12,3,6,5
|
0 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Occult blood;Week13;n=7,2,6,1,2,2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Occult blood;Week25;n=2,0,3,0,0,0
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Occult blood;Week37;n=3,0,1,0,0,0
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Occult blood;disc/prog;n=3,6,16,12,12,5
|
0 Participants
|
0 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
pH;Week5;n=8,7,18,12,14,8
|
6 Participants
|
3 Participants
|
8 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
pH;Week9;n=8,3,12,3,6,5
|
5 Participants
|
1 Participants
|
7 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
pH;Week49;n=1,0,1,0,0,0
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
pH;Week73;n=1,0,0,0,0,0
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
pH;Week85;n=1,0,0,0,0,0
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Protein;Week5;n=8,7,18,12,14,8
|
1 Participants
|
1 Participants
|
9 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Protein;Week9;n=8,3,12,3,6,5
|
3 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Protein;Week13;n=7,2,6,1,2,2
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Protein;Week37;n=1,0,1,0,0,0
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Protein;disc/prog;n=3,6,16,12,12,5
|
1 Participants
|
1 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Erythrocytes;Week5;n=3,3,8,4,4,4
|
2 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Erythrocytes;Week9;n=4,0,2,2,1,2
|
2 Participants
|
—
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Erythrocytes;Week13;n=3,1,0,0,0,1
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Specific gravity;Week5;n=8,7,18,12,14,8
|
4 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
7 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Specific gravity;Week9;n=8,3,12,3,6,5
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Specific gravity;Week13;n=7,2,6,1,2,2
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Specific gravity;disc/prog;n=3,6,16,12,12,5
|
0 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Leukocytes;Week5;n=3,3,8,4,4,4
|
1 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Leukocytes;Week9;n=4,0,2,2,1,3
|
0 Participants
|
—
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Leukocytes;Week13;n=3,1,0,0,0,1
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Leukocytes;Week25;n=2,0,1,0,0,0
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Leukocytes;disc/prog;n=1,2,7,3,4,1
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Week1 Day1), Weeks 5,9,17,25 and disc/progPopulation: All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
Urine samples were collected for the analysis of following urine parameters: pH, glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=5 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Erythrocytes; disc/prog; n=1,0
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Specific gravity; Week5; n=3,2
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Hyaline casts; Week5;n=1,1
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Hyaline casts; Week9;n=2,1
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Hyaline casts; Week17;n=1,0
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Hyaline casts; Week25;n=1,0
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Glucose; Week5;n=3,2
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Glucose; Week9;n=4,1
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Glucose; Week17;n=2,0
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Ketones; Week9;n=4,1
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
pH;Week5;n=3,2
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
pH;Week9;n=4,1
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
pH;Week17;n=2,0
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
pH;Week25;n=1,0
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
pH;disc/prog;n=2,2
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Protein; Week5; n=3,2
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Protein; Week9; n=4,1
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Protein; Week17; n=2,0
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Protein; Week25; n=1,0
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Erythrocytes; Week9; n=4,1
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Erythrocytes; Week17; n=2,0
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Erythrocytes; Week25; n=1,0
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Specific gravity; Week9; n=4,1
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Specific gravity; Week17; n=2,0
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Specific gravity; Week25; n=1,0
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Specific gravity; disc/prog; n=2,2
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Leukocytes; Week5; n=3,1
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Leukocytes; Week9; n=4,1
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Leukocytes; Week17; n=2,0
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Leukocytes; Week25; n=1,0
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Leukocytes; disc/prog; n=1,0
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposurePopulation: All Treated Population. Only those participants with data available at Baseline and the specified time point were analyzed.
Pulse rate was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for pulse rate is \<60 beats per minute and \>100 beats per minute. Participants were counted twice if the participant "Decreased to \<60" and "Increased to \>100" post-baseline. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=3 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=4 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=1 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=3 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=4 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=8 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=31 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
n=9 Participants
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Changes in Pulse Rate From Baseline-Part 1 QD
Pulse rate; decrease to <60
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Changes in Pulse Rate From Baseline-Part 1 QD
Pulse rate; Change to normal/no change
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
12 Participants
|
4 Participants
|
|
Number of Participants With Changes in Pulse Rate From Baseline-Part 1 QD
Pulse rate; increase to >100
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
18 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposurePopulation: All Treated Population
Pulse rate was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=4 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Changes in Pulse Rate From Baseline-Part 1 BID
Pulse rate; decrease to <60
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Changes in Pulse Rate From Baseline-Part 1 BID
Pulse rate; Change to normal/no change
|
3 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Changes in Pulse Rate From Baseline-Part 1 BID
Pulse rate; increase to >100
|
1 Participants
|
6 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposurePopulation: All Treated Population. Only those participants with data available at Baseline and the specified time points were analyzed.
Pulse rate was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for pulse rate is \<60 beats per minute and \>100 beats per minute. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented. Participants were counted twice if the participant "Decreased to \<60" and "Increased to \>100" post-baseline.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=11 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=14 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=22 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=19 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=20 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=12 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Changes in Pulse Rate From Baseline-Part 2
Pulse rate; decrease to <60
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Changes in Pulse Rate From Baseline-Part 2
Pulse rate; Change to normal/no change
|
7 Participants
|
10 Participants
|
13 Participants
|
11 Participants
|
9 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants With Changes in Pulse Rate From Baseline-Part 2
Pulse rate; increase to >100
|
5 Participants
|
4 Participants
|
9 Participants
|
9 Participants
|
10 Participants
|
3 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposurePopulation: All Treated Population
Pulse rate was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for pulse rate is \<60 beats per minute and \>100 beats per minute. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=5 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Changes in Pulse Rate From Baseline-Besylate Sub-study
Pulse rate; decrease to <60
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Changes in Pulse Rate From Baseline-Besylate Sub-study
Pulse rate; Change to normal/no change
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Changes in Pulse Rate From Baseline-Besylate Sub-study
Pulse rate; increase to >100
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposurePopulation: All Treated Population
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Grading of SBP and DBP were done using NCI-CTCAE version 4.0 where, SBP (millimeters of mercury): Grade 0 (\<120), Grade 1 (120-139), Grade 2 (140-159), Grade 3/4 (\>=160) and DBP: Grade 0 (\<80), Grade 1 (80-89), Grade 2 (90-99), Grade 3/4 (\>=100). An increase is defined as an increase in CTCAE grade relative to baseline grade. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=3 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=4 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=1 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=3 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=4 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=9 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=32 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
n=9 Participants
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Increase in Blood Pressure From Baseline-Part 1 QD
DBP; Increase to Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
10 Participants
|
1 Participants
|
|
Number of Participants With Increase in Blood Pressure From Baseline-Part 1 QD
DBP; Increase to Grade 3/4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Increase in Blood Pressure From Baseline-Part 1 QD
DBP; Increase to Grade 1
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
9 Participants
|
0 Participants
|
|
Number of Participants With Increase in Blood Pressure From Baseline-Part 1 QD
SBP; Increase to Grade 1
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
11 Participants
|
1 Participants
|
|
Number of Participants With Increase in Blood Pressure From Baseline-Part 1 QD
SBP; Increase to Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
9 Participants
|
3 Participants
|
|
Number of Participants With Increase in Blood Pressure From Baseline-Part 1 QD
SBP; Increase to Grade 3/4
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposurePopulation: All Treated Population. Only those participants with data available at Baseline and the specified time point were analyzed (indicated by n=X in category titles).
SBP and DBP were measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Grading of SBP and DBP were done using NCI-CTCAE version 4.0 where, SBP (millimeters of mercury): Grade 0 (\<120), Grade 1 (120-139), Grade 2 (140-159), Grade 3/4 (\>=160) and DBP: Grade 0 (\<80), Grade 1 (80-89), Grade 2 (90-99), Grade 3/4 (\>=100). An increase is defined as an increase in CTCAE grade relative to baseline grade. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=4 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Increase in Blood Pressure From Baseline-Part 1 BID
DBP; Increase to Grade 1;n=4,10,4
|
2 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Increase in Blood Pressure From Baseline-Part 1 BID
DBP; Increase to Grade 2;n=4,10,4
|
0 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Increase in Blood Pressure From Baseline-Part 1 BID
DBP; Increase to Grade 3/4;n=4,10,4
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Increase in Blood Pressure From Baseline-Part 1 BID
SBP; Increase to Grade 1;n=4,9,5
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Increase in Blood Pressure From Baseline-Part 1 BID
SBP; Increase to Grade 2;n=4,9,5
|
1 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Increase in Blood Pressure From Baseline-Part 1 BID
SBP; Increase to Grade 3/4;n=4,9,5
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposurePopulation: All Treated Population. Only those participants with data available at Baseline and the specified time points were analyzed (indicated by n=X in category titles).
SBP and DBP were measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Grading of SBP and DBP were done using NCI-CTCAE version 4.0 where, SBP (millimeters of mercury): Grade 0 (\<120), Grade 1 (120-139), Grade 2 (140-159), Grade 3/4 (\>=160) and DBP: Grade 0 (\<80), Grade 1 (80-89), Grade 2 (90-99), Grade 3/4 (\>=100). An increase is defined as an increase in CTCAE grade relative to baseline grade. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=11 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=14 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=22 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=19 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=19 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=12 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Changes in Blood Pressure From Baseline-Part 2
DBP; Increase to Grade 1;n=11,14,22,19,19,12
|
2 Participants
|
3 Participants
|
8 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Changes in Blood Pressure From Baseline-Part 2
DBP; Increase to Grade 2;n=11,14,22,19,19,12
|
4 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Changes in Blood Pressure From Baseline-Part 2
DBP; Increase to Grade 3/4;n=11,14,22,19,19,12
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Changes in Blood Pressure From Baseline-Part 2
SBP; Increase to Grade 1;n=11,14,21,19,19,12
|
4 Participants
|
4 Participants
|
2 Participants
|
9 Participants
|
7 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Changes in Blood Pressure From Baseline-Part 2
SBP; Increase to Grade 2;n=11,14,21,19,19,12
|
2 Participants
|
4 Participants
|
11 Participants
|
3 Participants
|
4 Participants
|
7 Participants
|
—
|
—
|
|
Number of Participants With Changes in Blood Pressure From Baseline-Part 2
SBP; Increase to Grade 3/4;n=11,14,21,19,19,12
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposurePopulation: All Treated Population
SBP and DBP were measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Grading of SBP and DBP were done using NCI-CTCAE version 4.0 where, SBP (millimeters of mercury): Grade 0 (\<120), Grade 1 (120-139), Grade 2 (140-159), Grade 3/4 (\>=160) and DBP: Grade 0 (\<80), Grade 1 (80-89), Grade 2 (90-99), Grade 3/4 (\>=100). An increase is defined as an increase in CTCAE grade relative to baseline grade. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=5 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Increase in Blood Pressure From Baseline-Besylate Sub-study
DBP; Increase to Grade 1
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Increase in Blood Pressure From Baseline-Besylate Sub-study
DBP; Increase to Grade 2
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Increase in Blood Pressure From Baseline-Besylate Sub-study
DBP; Increase to Grade 3/4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Increase in Blood Pressure From Baseline-Besylate Sub-study
SBP; Increase to Grade 1
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Increase in Blood Pressure From Baseline-Besylate Sub-study
SBP; Increase to Grade 2
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Increase in Blood Pressure From Baseline-Besylate Sub-study
SBP; Increase to Grade 3/4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposurePopulation: All Treated Population
Temperature was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for temperature is \<=35 degree Celsius and \>=38 degree Celsius. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=3 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=4 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=1 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=3 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=4 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=9 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=32 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
n=9 Participants
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Changes in Temperature From Baseline-Part 1 QD
Decrease to <=35
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Changes in Temperature From Baseline-Part 1 QD
Change to normal/No change
|
3 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
9 Participants
|
27 Participants
|
8 Participants
|
|
Number of Participants With Changes in Temperature From Baseline-Part 1 QD
Increase to >=38
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposurePopulation: All Treated Population
Temperature was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for temperature is \<=35 degree Celsius and \>=38 degree Celsius. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=4 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Changes in Temperature From Baseline-Part 1 BID
Decrease to <=35
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Changes in Temperature From Baseline-Part 1 BID
Change to normal/No change
|
4 Participants
|
9 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Changes in Temperature From Baseline-Part 1 BID
Increase to >=38
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposurePopulation: All Treated Population. Only those participants with data available at Baseline and the specified time points were analyzed.
Temperature was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for temperature is \<=35 degree Celsius and \>=38 degree Celsius. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=11 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=14 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=22 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=19 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=20 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=12 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Changes in Temperature From Baseline-Part 2
Decrease to <=35
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Changes in Temperature From Baseline-Part 2
Change to normal/No change
|
10 Participants
|
11 Participants
|
20 Participants
|
18 Participants
|
18 Participants
|
12 Participants
|
—
|
—
|
|
Number of Participants With Changes in Temperature From Baseline-Part 2
Increase to >=38
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposurePopulation: All Treated Population
Temperature was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for temperature is \<=35 degree Celsius and \>=38 degree Celsius. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=5 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Changes in Temperature From Baseline-Besylate Sub-study
Increase to >=38
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Changes in Temperature From Baseline-Besylate Sub-study
Decrease to <=35
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Changes in Temperature From Baseline-Besylate Sub-study
Change to normal/No change
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Median of 1.38 months of drug exposurePopulation: All Treated Population
Overall response rate is defined as the percentage of participants who achieved a confirmed complete response (CR) or partial response (PR) from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST version (v) 1.1). CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=3 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=4 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=1 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=3 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=4 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=9 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=32 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
n=9 Participants
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate-Part 1 QD
|
0 Percentage of participants
Interval 0.0 to 70.8
|
25 Percentage of participants
Interval 0.6 to 80.6
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 33.6
|
3 Percentage of participants
Interval 0.1 to 16.2
|
11 Percentage of participants
Interval 0.3 to 48.2
|
PRIMARY outcome
Timeframe: Median of 1.41 months of drug exposurePopulation: All Treated Population
Overall response rate is defined as the percentage of participants who achieved a confirmed CR or PR from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=4 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate-Part 1 BID
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 30.8
|
0 Percentage of participants
Interval 0.0 to 52.2
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Median of 1.41 months of drug exposurePopulation: All Treated Population
Overall response rate is defined as the percentage of participants who achieved a confirmed CR or PR from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=12 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=14 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=23 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=19 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=21 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=13 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate-Part 2
|
8 Percentage of participants
Interval 0.2 to 38.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
4 Percentage of participants
Interval 0.1 to 21.9
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 16.1
|
0 Percentage of participants
Interval 0.0 to 24.7
|
—
|
—
|
PRIMARY outcome
Timeframe: Median of 1.87 months of drug exposurePopulation: All Treated Population. Data for Besylate sub-study participants were combined for analysis to provide useful interpretation of study data as pre-specified in RAP.
Overall response rate is defined as the percentage of participants who achieved a confirmed CR or PR from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=10 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate-Besylate Sub-study
|
0 Percentage of participants
Interval 0.0 to 30.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Median of 1.38 months of drug exposurePopulation: All Treated Population
PSA 50 response rate is defined as the response rate that a PSA reduction from Baseline \>=50% is observed at 12 weeks and beyond (must be confirmed by a second value). The number of participants with PSA \>=50% reduction is presented along with 95% confidence intervals.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=3 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=4 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=1 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=3 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=4 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=9 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=32 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
n=9 Participants
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Prostate Specific Antigen (PSA)50 Response-Part 1 QD
|
0 Participants
Confidence interval could not be calculated as there were no responders
|
0 Participants
Confidence interval could not be calculated as there were no responders
|
0 Participants
Confidence interval could not be calculated as there were no responders
|
0 Participants
Confidence interval could not be calculated as there were no responders
|
0 Participants
Confidence interval could not be calculated as there were no responders
|
0 Participants
Confidence interval could not be calculated as there were no responders
|
2 Participants
Confidence interval could not be calculated as there were no responders
|
1 Participants
Confidence interval could not be calculated as there were no responders
|
PRIMARY outcome
Timeframe: Median of 1.41 months of drug exposurePopulation: All Treated Population
PSA 50 Response rate is defined as the response rate that a PSA reduction from Baseline \>=50% is observed at 12 weeks and beyond (must be confirmed by a second value). The number of participants with PSA \>=50% reduction is presented along with 95% confidence intervals.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=4 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With PSA50 Response Rate-Part 1 BID
|
0 Participants
Confidence interval could not be calculated as there were no responders
|
0 Participants
Confidence interval could not be calculated as there were no responders
|
0 Participants
Confidence interval could not be calculated as there were no responders
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Median of 1.41 months of drug exposurePopulation: All Treated Population
PSA 50 response rate is defined as the response rate that a PSA reduction from Baseline \>=50% is observed at 12 weeks and beyond (must be confirmed by a second value). The number of participants with PSA \>=50% reduction is presented along with 95% confidence intervals.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=12 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=14 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=23 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=19 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=21 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=13 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With PSA50 Response-Part 2
|
0 Participants
Confidence interval could not be calculated as there were no responders
|
0 Participants
Confidence interval could not be calculated as there were no responders
|
0 Participants
Confidence interval could not be calculated as there were no responders
|
0 Participants
Confidence interval could not be calculated as there were no responders
|
0 Participants
Confidence interval could not be calculated as there were no responders
|
0 Participants
Confidence interval could not be calculated as there were no responders
|
—
|
—
|
PRIMARY outcome
Timeframe: Median of 1.87 months of drug exposurePopulation: All Treated Population
PSA 50 Response rate is defined as the response rate that a PSA reduction from Baseline \>=50% is observed at 12 weeks and beyond (must be confirmed by a second value). The number of participants with PSA \>=50% reduction is presented along with 95% confidence intervals.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=5 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With PSA50 Response-Besylate Sub-study
|
0 Participants
Confidence interval could not be calculated as there were no responders
|
0 Participants
Confidence interval could not be calculated as there were no responders
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week1 Day1, Day3 and Week2 Day1 (pre-dose,0.25,0.5,1,1.5,2,3,4,6,8,24,48 hours post-dose)Population: Besylate Sub-Study PK Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples for pharmacokinetic analysis of GSK525762 were collected at the indicated time points. Besylate sub-study pharmacokinetic (PK) Parameter Population consisted of all participants in the PK Parameter Population who participated in the besylate substudy.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=9 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=8 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve (AUC) From Time Zero to 24 Hours(AUC[0 to 24]); AUC From Time 0 to Last Quantifiable Concentration (AUC [0 to t]) and AUC Extrapolated to Infinity (AUC[0 to Inf]) of GSK525762-Besylate Sub-study
AUC(0 to 24)
|
6954.3 Hours*nanograms per milliliter
Geometric Coefficient of Variation 59.1
|
7377.9 Hours*nanograms per milliliter
Geometric Coefficient of Variation 44.7
|
2977.3 Hours*nanograms per milliliter
Geometric Coefficient of Variation 42.8
|
9123.8 Hours*nanograms per milliliter
Geometric Coefficient of Variation 45.2
|
—
|
—
|
—
|
—
|
|
Area Under the Concentration-time Curve (AUC) From Time Zero to 24 Hours(AUC[0 to 24]); AUC From Time 0 to Last Quantifiable Concentration (AUC [0 to t]) and AUC Extrapolated to Infinity (AUC[0 to Inf]) of GSK525762-Besylate Sub-study
AUC(0 to inf)
|
7292.0 Hours*nanograms per milliliter
Geometric Coefficient of Variation 62.1
|
7703.4 Hours*nanograms per milliliter
Geometric Coefficient of Variation 49.9
|
3096.9 Hours*nanograms per milliliter
Geometric Coefficient of Variation 45.0
|
9727.7 Hours*nanograms per milliliter
Geometric Coefficient of Variation 48.5
|
—
|
—
|
—
|
—
|
|
Area Under the Concentration-time Curve (AUC) From Time Zero to 24 Hours(AUC[0 to 24]); AUC From Time 0 to Last Quantifiable Concentration (AUC [0 to t]) and AUC Extrapolated to Infinity (AUC[0 to Inf]) of GSK525762-Besylate Sub-study
AUC(0 to t)
|
7227.1 Hours*nanograms per milliliter
Geometric Coefficient of Variation 61.6
|
7657.6 Hours*nanograms per milliliter
Geometric Coefficient of Variation 49.9
|
3053.9 Hours*nanograms per milliliter
Geometric Coefficient of Variation 44.4
|
9597.1 Hours*nanograms per milliliter
Geometric Coefficient of Variation 48.9
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week1 Day1, Day3 and Week2 Day1 (pre-dose,0.25,0.5,1,1.5,2,3,4,6,8,24,48 hours post-dose)Population: Besylate Sub-Study PK Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples for pharmacokinetic analysis of GSK525762 were collected at the indicated time points.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=9 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=8 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of GSK525762-Besylate Sub-study
|
1431.41 Nanograms per milliliter
Geometric Coefficient of Variation 51.3
|
1483.21 Nanograms per milliliter
Geometric Coefficient of Variation 49.8
|
655.33 Nanograms per milliliter
Geometric Coefficient of Variation 21.1
|
1305.59 Nanograms per milliliter
Geometric Coefficient of Variation 46.6
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week1 Day1, Day3 and Week2 Day1 (pre-dose,0.25,0.5,1,1.5,2,3,4,6,8,24,48 hours post-dose)Population: Besylate Sub-Study PK Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples for pharmacokinetic analysis of GSK525762 were collected at the indicated time points.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=9 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=8 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Terminal Phase Elimination Rate Constant (Lambda z) for GSK525762-Besylate Sub-study
|
5.628 Per hour
Geometric Coefficient of Variation 25.9
|
5.176 Per hour
Geometric Coefficient of Variation 20.6
|
5.088 Per hour
Geometric Coefficient of Variation 23.8
|
5.954 Per hour
Geometric Coefficient of Variation 20.2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week1 Day1, Day3 and Week2 Day1 (pre-dose,0.25,0.5,1,1.5,2,3,4,6,8,24,48 hours post-dose)Population: Besylate Sub-Study PK Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples for pharmacokinetic analysis of GSK525762 were collected at the indicated time points.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=9 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=8 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Reach Cmax (Tmax) for GSK525762-Besylate Sub-study
|
0.5833 Hours
Interval 0.25 to 3.25
|
0.8083 Hours
Interval 0.5 to 3.0
|
0.8333 Hours
Interval 0.3 to 1.017
|
2.0000 Hours
Interval 0.5 to 6.05
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Median of 1.87 months of drug exposurePopulation: All Treated Population
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=5 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Non-serious AEs and SAEs-Besylate Sub-study
Any non-serious AE
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Non-serious AEs and SAEs-Besylate Sub-study
Any SAE
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Median of 1.38 months of drug exposurePopulation: All Treated Population
Electrocardiogram (ECG) measurements were done using an automated 12-lead ECG machine. QTc parameters were graded according to NCI-CTCAE version 4.0. Grade 0 (\<450 milliseconds \[msec\]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), Grade 3 (\>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Number of participants with increase in QTcF at worst-case post Baseline is reported.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=3 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=4 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=1 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=3 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=4 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=9 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=32 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
n=9 Participants
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Increase in QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF)-Part 1 QD
Any Grade increase
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
13 Participants
|
4 Participants
|
|
Number of Participants With Increase in QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF)-Part 1 QD
Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Increase in QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF)-Part 1 QD
Increase to Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Median of 1.41 months of drug exposurePopulation: All Treated Population
ECG measurements were done using an automated 12-lead ECG machine. QTc parameters were graded according to NCI-CTCAE version 4.0. Grade 0 (\<450 milliseconds \[msec\]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), Grade 3 (\>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Number of participants with increase in QTcF at worst-case post Baseline is reported.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=4 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Increase in QTcF-Part 1 BID
Any Grade increase
|
3 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Increase in QTcF-Part 1 BID
Increase to Grade 2
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Increase in QTcF-Part 1 BID
Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Median of 1.41 months of drug exposurePopulation: All Treated Population. Only those participants with data available at the specified time point were analyzed.
ECG measurements were done using an automated 12-lead ECG machine. QTc parameters were graded according to NCI-CTCAE version 4.0. Grade 0 (\<450 milliseconds \[msec\]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), Grade 3 (\>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Number of participants with increase in QTcF at worst-case post Baseline is reported.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=11 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=14 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=22 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=19 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=20 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=12 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Increase in QTcF-Part 2
Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Increase in QTcF-Part 2
Increase to Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Increase in QTcF-Part 2
Any Grade increase
|
1 Participants
|
2 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Median of 1.87 months of drug exposurePopulation: All Treated Population
ECG measurements were done using 12-lead ECG machine that automatically calculated the heart rate and measured PR, QRS, QT and QTcF intervals. QTc parameters were graded according to NCI-CTCAE version 4.0. Grade 0 (\<450 milliseconds \[msec\]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), Grade 3 (\>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Number of participants with increase in QTcF at worst-case post Baseline is reported.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=5 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Increase in QTcF-Besylate Sub-study
Any Grade increase
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Increase in QTcF-Besylate Sub-study
Increase to Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Increase in QTcF-Besylate Sub-study
Increase to Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Median of 1.38 months of drug exposurePopulation: All Treated Population
Progression free survival is defined as the interval of time (in months) between the date of first dose and the earlier of the date of disease progression and date of death due to any cause. Confidence intervals were estimated using Brookmeyer Crowley method.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=3 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=4 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=1 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=3 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=4 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=9 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=32 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
n=9 Participants
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival-Part 1 QD
|
0.3 Months
Interval 0.3 to 0.4
|
4.1 Months
Interval 0.9 to 13.9
|
2.2 Months
Confidence interval could not be calculated as only one participant was analyzed
|
9.1 Months
Interval 1.4 to 13.9
|
3.8 Months
Interval 0.9 to 5.4
|
3.6 Months
Interval 1.4 to 8.9
|
6.5 Months
Interval 2.6 to 9.1
|
7.5 Months
Interval 6.0 to 18.0
|
SECONDARY outcome
Timeframe: Median of 1.41 months of drug exposurePopulation: All Treated Population
Progression free survival is defined as the interval of time (in months) between the date of first dose and the earlier of the date of disease progression and date of death due to any cause. Confidence intervals were estimated using Brookmeyer Crowley method.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=4 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival-Part 1 BID
|
7.7 Months
Interval 0.9 to 14.5
|
5.6 Months
Interval 2.9 to 7.0
|
8.0 Months
Interval 7.9 to 18.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Median of 1.41 months of drug exposurePopulation: All Treated Population
Progression free survival is defined as the interval of time (in months) between the date of first dose and the earlier of the date of disease progression and the date of death due to any cause. Confidence intervals were estimated using Brookmeyer Crowley method.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=12 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=14 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=23 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=19 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=21 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=13 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival-Part 2
|
4.8 Months
Interval 2.5 to 5.1
|
2.2 Months
Interval 1.1 to 5.3
|
8.0 Months
Interval 5.5 to 11.7
|
2.4 Months
Interval 1.4 to 6.5
|
4.7 Months
Interval 3.3 to 9.2
|
3.4 Months
Interval 1.9 to 7.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Median of 1.87 months of drug exposurePopulation: All Treated Population. Data for Besylate sub-study participants were combined for analysis to provide useful interpretation of study data as pre-specified in RAP.
Progression free survival is defined as the interval of time (in months) between the date of first dose and the earlier of the date of disease progression and the date of death due to any cause. Confidence intervals were estimated using Brookmeyer Crowley method.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=10 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival-Besylate Sub-study
|
3.5 Months
Interval 1.0 to 10.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Median of 1.38 months of drug exposurePopulation: All Treated Population. Participants with incomplete response dates were excluded from the analysis.
Time to response is defined, for participants with a confirmed CR or PR, as the time from first dose to the first documented evidence of CR or PR. Time to response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Median of 1.41 months of drug exposurePopulation: All Treated Population. Participants with incomplete response dates were excluded from the analysis.
Time to response is defined, for participants with a confirmed CR or PR, as the time from first dose to the first documented evidence of CR or PR. Time to response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Median of 1.41 months of drug exposurePopulation: All Treated Population. Participants with incomplete response dates were excluded from the analysis.
Time to response is defined, for participants with a confirmed CR or PR, as the time from first dose to the first documented evidence of CR or PR. Time to response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Median of 1.87 months of drug exposurePopulation: All Treated Population. Participants with incomplete response dates were excluded from the analysis.
Time to response is defined, for participants with a confirmed CR or PR, as the time from first dose to the first documented evidence of CR or PR. Time to response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Median of 1.38 months of drug exposurePopulation: All Treated Population. Participants with incomplete response dates were excluded from the analysis.
Duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve a confirmed CR or PR. Duration of response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Median of 1.41 months of drug exposurePopulation: All Treated Population. Participants with incomplete response dates were excluded from the analysis.
Duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve a confirmed CR or PR. Duration of response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Median of 1.41 months of drug exposurePopulation: All Treated Population. Participants with incomplete response dates were excluded from the analysis.
Duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve a confirmed CR or PR. Duration of response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Median of 1.87 months of drug exposurePopulation: All Treated Population. Participants with incomplete response dates were excluded from the analysis.
Duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve a confirmed CR or PR. Duration of response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Median of 1.38 months of drug exposurePopulation: All Treated Population
Overall survival is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. The median overall survival is presented along with 95% confidence interval. Confidence intervals were estimated using Brookmeyer Crowley method.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=3 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=4 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=1 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=3 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=4 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=9 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=32 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
n=9 Participants
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Survival-Part 1 QD
|
0.6 Months
Interval 0.3 to
The upper limit of the 95% CI could not be estimated due to the low number of participants being analyzed.
|
4.1 Months
Interval 0.9 to 13.9
|
2.2 Months
Confidence interval could not be calculated as only one participant was analyzed
|
9.1 Months
Interval 5.6 to 13.9
|
3.8 Months
Interval 2.8 to 5.4
|
8.9 Months
Interval 3.6 to 20.2
|
7.1 Months
Interval 3.9 to 9.5
|
9.8 Months
Interval 6.0 to 18.0
|
SECONDARY outcome
Timeframe: Median of 1.41 months of drug exposurePopulation: All Treated Population
Overall survival is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. The median overall survival is presented along with 95% confidence interval. Confidence intervals were estimated using Brookmeyer Crowley method.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=4 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Survival-Part 1 BID
|
NA Months
Interval 14.5 to
Values could not be estimated due to limited amount of observed follow-up time.
|
6.0 Months
Interval 2.9 to 12.2
|
13.3 Months
Interval 7.9 to 18.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Median of 1.41 months of drug exposurePopulation: All Treated Population
Overall survival is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. The median overall survival is presented along with 95% confidence interval. Confidence intervals were estimated using Brookmeyer Crowley method.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=12 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=14 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=23 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=19 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=21 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=13 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Survival-Part 2
|
5.0 Months
Interval 4.3 to
The upper limit of the 95% CI could not be estimated due to the low number of participants being analyzed.
|
2.6 Months
Interval 1.1 to 9.4
|
9.1 Months
Interval 6.7 to 11.7
|
5.0 Months
Interval 2.3 to 10.3
|
8.8 Months
Interval 3.6 to 13.1
|
7.3 Months
Interval 3.4 to
The upper limit of the 95% CI could not be estimated due to the low number of participants being analyzed.
|
—
|
—
|
SECONDARY outcome
Timeframe: Median of 1.87 months of drug exposurePopulation: All Treated Population. Data for Besylate sub-study participants were combined for analysis to provide useful interpretation of study data as pre-specified in RAP.
Overall survival is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. The median overall survival is presented along with 95% confidence interval. Confidence intervals were estimated using Brookmeyer Crowley method.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=10 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Survival-Besylate Sub-study
|
6.3 Months
Interval 3.6 to 10.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4Population: PK Parameter Population. Only those participants with data available at the specified time points were available (indicated by n=X in category titles)
Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762. PK parameter population comprised of all participants in the PK Concentration Population (all participants in the All Treated Population for whom a blood sample for pharmacokinetics is obtained and analyzed) for whom a PK parameter has been obtained.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=3 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=4 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=1 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=3 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=4 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=9 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=32 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
n=9 Participants
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
AUC (0 to t), AUC (0 to 24) and AUC (0 to Inf) of GSK525762-Part 1 QD
AUC (0 to 24); Week1;n=3,4,1,3,4,9,32,9
|
169.2 Hours*nanogram per milliliter
Geometric Coefficient of Variation 39.4
|
354.3 Hours*nanogram per milliliter
Geometric Coefficient of Variation 33.8
|
431.5 Hours*nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
|
867.9 Hours*nanogram per milliliter
Geometric Coefficient of Variation 39.5
|
3943.2 Hours*nanogram per milliliter
Geometric Coefficient of Variation 49.5
|
4225.0 Hours*nanogram per milliliter
Geometric Coefficient of Variation 39.2
|
5692.4 Hours*nanogram per milliliter
Geometric Coefficient of Variation 61.4
|
6958.3 Hours*nanogram per milliliter
Geometric Coefficient of Variation 43.5
|
|
AUC (0 to t), AUC (0 to 24) and AUC (0 to Inf) of GSK525762-Part 1 QD
AUC (0 to 24); Week3;n=1,2,1,3,4,6,16,6
|
152.9 Hours*nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
|
334.6 Hours*nanogram per milliliter
Geometric Coefficient of Variation 60.5
|
329.5 Hours*nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
|
671.6 Hours*nanogram per milliliter
Geometric Coefficient of Variation 21.4
|
3146.2 Hours*nanogram per milliliter
Geometric Coefficient of Variation 54.5
|
2575.6 Hours*nanogram per milliliter
Geometric Coefficient of Variation 47.3
|
2959.8 Hours*nanogram per milliliter
Geometric Coefficient of Variation 48.4
|
3818.5 Hours*nanogram per milliliter
Geometric Coefficient of Variation 35.8
|
|
AUC (0 to t), AUC (0 to 24) and AUC (0 to Inf) of GSK525762-Part 1 QD
AUC (0 to inf); Week1;n=3,4,1,3,4,9,32,9
|
174.4 Hours*nanogram per milliliter
Geometric Coefficient of Variation 44.3
|
360.8 Hours*nanogram per milliliter
Geometric Coefficient of Variation 35.1
|
433.1 Hours*nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
|
887.1 Hours*nanogram per milliliter
Geometric Coefficient of Variation 39.1
|
4464.5 Hours*nanogram per milliliter
Geometric Coefficient of Variation 62.9
|
4357.5 Hours*nanogram per milliliter
Geometric Coefficient of Variation 42.1
|
5887.2 Hours*nanogram per milliliter
Geometric Coefficient of Variation 62.8
|
7295.6 Hours*nanogram per milliliter
Geometric Coefficient of Variation 45.2
|
|
AUC (0 to t), AUC (0 to 24) and AUC (0 to Inf) of GSK525762-Part 1 QD
AUC (0 to t); Week1;n=3,4,1,3,4,9,32,9
|
168.6 Hours*nanogram per milliliter
Geometric Coefficient of Variation 44.5
|
357.5 Hours*nanogram per milliliter
Geometric Coefficient of Variation 34.8
|
431.1 Hours*nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
|
877.7 Hours*nanogram per milliliter
Geometric Coefficient of Variation 39.4
|
4147.8 Hours*nanogram per milliliter
Geometric Coefficient of Variation 54.3
|
4304.1 Hours*nanogram per milliliter
Geometric Coefficient of Variation 40.7
|
5667.3 Hours*nanogram per milliliter
Geometric Coefficient of Variation 61.5
|
7218.4 Hours*nanogram per milliliter
Geometric Coefficient of Variation 45.1
|
|
AUC (0 to t), AUC (0 to 24) and AUC (0 to Inf) of GSK525762-Part 1 QD
AUC (0 to t); Week3;n=1,2,1,3,4,6,16,6
|
152.8 Hours*nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
|
334.3 Hours*nanogram per milliliter
Geometric Coefficient of Variation 60.3
|
330.6 Hours*nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
|
672.3 Hours*nanogram per milliliter
Geometric Coefficient of Variation 21.5
|
3164.3 Hours*nanogram per milliliter
Geometric Coefficient of Variation 54.7
|
2576.9 Hours*nanogram per milliliter
Geometric Coefficient of Variation 47.3
|
2953.8 Hours*nanogram per milliliter
Geometric Coefficient of Variation 49.0
|
3819.9 Hours*nanogram per milliliter
Geometric Coefficient of Variation 35.9
|
SECONDARY outcome
Timeframe: pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4Population: PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=3 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=4 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=1 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=3 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=4 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=9 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=32 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
n=9 Participants
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration for GSK525762-Part 1 QD
Week1;n=3,4,1,3,4,9,32,9
|
50.95 Nanogram per milliliter
Geometric Coefficient of Variation 41.5
|
70.46 Nanogram per milliliter
Geometric Coefficient of Variation 29.2
|
120.35 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
|
179.45 Nanogram per milliliter
Geometric Coefficient of Variation 39.9
|
603.92 Nanogram per milliliter
Geometric Coefficient of Variation 30.3
|
889.52 Nanogram per milliliter
Geometric Coefficient of Variation 24.5
|
1099.81 Nanogram per milliliter
Geometric Coefficient of Variation 62.7
|
1080.49 Nanogram per milliliter
Geometric Coefficient of Variation 38.8
|
|
Maximum Observed Concentration for GSK525762-Part 1 QD
Week3;n=1,2,1,3,4,6,16,6
|
52.04 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
|
53.37 Nanogram per milliliter
Geometric Coefficient of Variation 16.3
|
103.18 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
|
137.57 Nanogram per milliliter
Geometric Coefficient of Variation 25.1
|
602.70 Nanogram per milliliter
Geometric Coefficient of Variation 17.2
|
633.71 Nanogram per milliliter
Geometric Coefficient of Variation 52.6
|
815.40 Nanogram per milliliter
Geometric Coefficient of Variation 41.1
|
918.56 Nanogram per milliliter
Geometric Coefficient of Variation 41.4
|
SECONDARY outcome
Timeframe: pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4Population: PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=3 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=4 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=1 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=3 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=4 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=9 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=32 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
n=9 Participants
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Lambda z for GSK525762-Part 1 QD
Week1;n=3,4,1,3,4,9,32,9
|
0.21411 Per hour
Geometric Coefficient of Variation 98.4
|
0.13554 Per hour
Geometric Coefficient of Variation 37.4
|
0.23126 Per hour
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
|
0.09903 Per hour
Geometric Coefficient of Variation 43.5
|
0.07863 Per hour
Geometric Coefficient of Variation 53.1
|
0.12468 Per hour
Geometric Coefficient of Variation 28.2
|
0.15613 Per hour
Geometric Coefficient of Variation 34.1
|
0.10992 Per hour
Geometric Coefficient of Variation 16.0
|
|
Lambda z for GSK525762-Part 1 QD
Week3;n=1,2,1,3,4,6,16,6
|
0.15579 Per hour
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
|
0.15472 Per hour
Geometric Coefficient of Variation 11.2
|
0.14087 Per hour
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
|
0.15599 Per hour
Geometric Coefficient of Variation 21.7
|
0.12513 Per hour
Geometric Coefficient of Variation 12.7
|
0.17629 Per hour
Geometric Coefficient of Variation 26.3
|
0.16667 Per hour
Geometric Coefficient of Variation 30.6
|
0.17560 Per hour
Geometric Coefficient of Variation 21.1
|
SECONDARY outcome
Timeframe: pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4Population: PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=3 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=4 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=1 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=3 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=4 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=9 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=32 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
n=9 Participants
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Tmax for GSK525762-Part 1 QD
Week1;n=3,4,1,3,4,9,32,9
|
0.5833 Hours
Interval 0.5 to 0.633
|
1.2250 Hours
Interval 0.5 to 2.0
|
1.1000 Hours
Interval 1.1 to 1.1
|
2.0167 Hours
Interval 0.333 to 3.967
|
2.0083 Hours
Interval 0.967 to 2.233
|
1.0000 Hours
Interval 0.517 to 4.0
|
1.0000 Hours
Interval 0.25 to 4.0
|
1.0000 Hours
Interval 0.667 to 3.95
|
|
Tmax for GSK525762-Part 1 QD
Week3;n=1,2,1,3,4,6,16,6
|
1.0000 Hours
Interval 1.0 to 1.0
|
2.5083 Hours
Interval 1.017 to 4.0
|
0.5000 Hours
Interval 0.5 to 0.5
|
1.0500 Hours
Interval 0.767 to 4.0
|
0.9000 Hours
Interval 0.317 to 4.0
|
1.0583 Hours
Interval 0.5 to 2.033
|
0.5667 Hours
Interval 0.3 to 4.017
|
1.5000 Hours
Interval 0.5 to 2.0
|
SECONDARY outcome
Timeframe: pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4Population: PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=3 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=4 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=1 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=3 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=4 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=9 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=32 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
n=9 Participants
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Clearance of GSK525762-Part 1 QD
Week1;n=3,4,1,3,4,9,32,9
|
11.467 Liter per hour
Geometric Coefficient of Variation 44.3
|
11.085 Liter per hour
Geometric Coefficient of Variation 35.1
|
18.470 Liter per hour
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
|
18.036 Liter per hour
Geometric Coefficient of Variation 39.1
|
6.720 Liter per hour
Geometric Coefficient of Variation 62.9
|
13.769 Liter per hour
Geometric Coefficient of Variation 42.1
|
13.589 Liter per hour
Geometric Coefficient of Variation 62.8
|
13.707 Liter per hour
Geometric Coefficient of Variation 45.2
|
|
Apparent Clearance of GSK525762-Part 1 QD
Week3;n=1,2,1,3,4,6,16,6
|
13.082 Liter per hour
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
|
11.955 Liter per hour
Geometric Coefficient of Variation 60.5
|
24.277 Liter per hour
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
|
23.823 Liter per hour
Geometric Coefficient of Variation 21.4
|
9.535 Liter per hour
Geometric Coefficient of Variation 54.5
|
23.296 Liter per hour
Geometric Coefficient of Variation 47.3
|
27.029 Liter per hour
Geometric Coefficient of Variation 48.4
|
26.188 Liter per hour
Geometric Coefficient of Variation 35.8
|
SECONDARY outcome
Timeframe: pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4Population: PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=3 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=4 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=1 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=3 Participants
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=4 Participants
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=9 Participants
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=32 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
n=9 Participants
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution of GSK525762-Part 1 QD
Week1;n=3,4,1,3,4,9,32,9
|
53.56 Liters
Geometric Coefficient of Variation 65.9
|
81.79 Liters
Geometric Coefficient of Variation 34.7
|
79.87 Liters
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
|
182.13 Liters
Geometric Coefficient of Variation 92.7
|
85.46 Liters
Geometric Coefficient of Variation 30.3
|
110.44 Liters
Geometric Coefficient of Variation 23.5
|
87.03 Liters
Geometric Coefficient of Variation 56.4
|
124.70 Liters
Geometric Coefficient of Variation 42.6
|
|
Volume of Distribution of GSK525762-Part 1 QD
Week3;n=1,2,1,3,4,6,16,6
|
83.97 Liters
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
|
77.27 Liters
Geometric Coefficient of Variation 47.0
|
172.33 Liters
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
|
152.72 Liters
Geometric Coefficient of Variation 44.5
|
76.20 Liters
Geometric Coefficient of Variation 44.0
|
132.14 Liters
Geometric Coefficient of Variation 34.7
|
162.17 Liters
Geometric Coefficient of Variation 40.6
|
149.14 Liters
Geometric Coefficient of Variation 26.9
|
SECONDARY outcome
Timeframe: pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4Population: PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=4 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
AUC (0 to Inf), AUC (0 to 24) and AUC (0 to t) of GSK525762-Part 1 BID
AUC (0 to 24); Week1 AM dose;n=3,10,5
|
856.1 Hours*nanogram per milliter
Geometric Coefficient of Variation 123.7
|
3067.0 Hours*nanogram per milliter
Geometric Coefficient of Variation 43.9
|
2794.4 Hours*nanogram per milliter
Geometric Coefficient of Variation 31.8
|
—
|
—
|
—
|
—
|
—
|
|
AUC (0 to Inf), AUC (0 to 24) and AUC (0 to t) of GSK525762-Part 1 BID
AUC (0 to 24); Week1 PM dose;n=4,7,5
|
981.4 Hours*nanogram per milliter
Geometric Coefficient of Variation 84.8
|
3261.1 Hours*nanogram per milliter
Geometric Coefficient of Variation 59.9
|
2607.6 Hours*nanogram per milliter
Geometric Coefficient of Variation 36.2
|
—
|
—
|
—
|
—
|
—
|
|
AUC (0 to Inf), AUC (0 to 24) and AUC (0 to t) of GSK525762-Part 1 BID
AUC (0 to 24); Week3 AM dose;n=3,7,3
|
1279.0 Hours*nanogram per milliter
Geometric Coefficient of Variation 116.2
|
2725.3 Hours*nanogram per milliter
Geometric Coefficient of Variation 92.4
|
1184.6 Hours*nanogram per milliter
Geometric Coefficient of Variation 17.8
|
—
|
—
|
—
|
—
|
—
|
|
AUC (0 to Inf), AUC (0 to 24) and AUC (0 to t) of GSK525762-Part 1 BID
AUC (0 to 24); Week3 PM dose;n=3,5,3
|
1155.8 Hours*nanogram per milliter
Geometric Coefficient of Variation 102.4
|
1662.1 Hours*nanogram per milliter
Geometric Coefficient of Variation 29.2
|
1131.6 Hours*nanogram per milliter
Geometric Coefficient of Variation 28.5
|
—
|
—
|
—
|
—
|
—
|
|
AUC (0 to Inf), AUC (0 to 24) and AUC (0 to t) of GSK525762-Part 1 BID
AUC (0 to inf); Week1 AM dose;n=3,10,5
|
860.4 Hours*nanogram per milliter
Geometric Coefficient of Variation 124.4
|
3118.3 Hours*nanogram per milliter
Geometric Coefficient of Variation 45.3
|
2825.8 Hours*nanogram per milliter
Geometric Coefficient of Variation 32.8
|
—
|
—
|
—
|
—
|
—
|
|
AUC (0 to Inf), AUC (0 to 24) and AUC (0 to t) of GSK525762-Part 1 BID
AUC (0 to t); Week1 AM dose;n=4,10,5
|
932.2 Hours*nanogram per milliter
Geometric Coefficient of Variation 97.6
|
2727.2 Hours*nanogram per milliter
Geometric Coefficient of Variation 40.8
|
2579.0 Hours*nanogram per milliter
Geometric Coefficient of Variation 28.0
|
—
|
—
|
—
|
—
|
—
|
|
AUC (0 to Inf), AUC (0 to 24) and AUC (0 to t) of GSK525762-Part 1 BID
AUC (0 to t); Week1 PM dose;n=4,9,5
|
927.5 Hours*nanogram per milliter
Geometric Coefficient of Variation 82.5
|
2840.4 Hours*nanogram per milliter
Geometric Coefficient of Variation 43.4
|
2446.7 Hours*nanogram per milliter
Geometric Coefficient of Variation 34.2
|
—
|
—
|
—
|
—
|
—
|
|
AUC (0 to Inf), AUC (0 to 24) and AUC (0 to t) of GSK525762-Part 1 BID
AUC (0 to t); Week3 AM dose;n=3,7,3
|
1194.6 Hours*nanogram per milliter
Geometric Coefficient of Variation 110.1
|
2472.4 Hours*nanogram per milliter
Geometric Coefficient of Variation 89.8
|
1140.9 Hours*nanogram per milliter
Geometric Coefficient of Variation 16.9
|
—
|
—
|
—
|
—
|
—
|
|
AUC (0 to Inf), AUC (0 to 24) and AUC (0 to t) of GSK525762-Part 1 BID
AUC (0 to t); Week3 PM dose;n=3,6,3
|
1053.6 Hours*nanogram per milliter
Geometric Coefficient of Variation 96.6
|
1490.8 Hours*nanogram per milliter
Geometric Coefficient of Variation 23.3
|
1073.6 Hours*nanogram per milliter
Geometric Coefficient of Variation 29.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4Population: PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=4 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration of GSK525762-Part 1 BID
Week1 AM dose;n=4,10,5
|
231.68 Nanogram per milliter
Geometric Coefficient of Variation 70.6
|
628.01 Nanogram per milliter
Geometric Coefficient of Variation 40.0
|
703.31 Nanogram per milliter
Geometric Coefficient of Variation 34.2
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Concentration of GSK525762-Part 1 BID
Week1 PM dose;n=4,9,5
|
166.62 Nanogram per milliter
Geometric Coefficient of Variation 62.0
|
445.17 Nanogram per milliter
Geometric Coefficient of Variation 27.6
|
425.76 Nanogram per milliter
Geometric Coefficient of Variation 29.3
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Concentration of GSK525762-Part 1 BID
Week3 AM dose;n=3,7,3
|
284.71 Nanogram per milliter
Geometric Coefficient of Variation 87.1
|
604.38 Nanogram per milliter
Geometric Coefficient of Variation 66.4
|
419.15 Nanogram per milliter
Geometric Coefficient of Variation 18.1
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Concentration of GSK525762-Part 1 BID
Week3 PM dose;n=3,6,3
|
256.08 Nanogram per milliter
Geometric Coefficient of Variation 94.0
|
263.72 Nanogram per milliter
Geometric Coefficient of Variation 41.3
|
229.91 Nanogram per milliter
Geometric Coefficient of Variation 34.8
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4Population: PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=4 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Lambda z for GSK525762-Part 1 BID
Week1 AM dose;n=3,10,5
|
0.23463 Per hour
Geometric Coefficient of Variation 19.4
|
0.19989 Per hour
Geometric Coefficient of Variation 29.6
|
0.23721 Per hour
Geometric Coefficient of Variation 39.4
|
—
|
—
|
—
|
—
|
—
|
|
Lambda z for GSK525762-Part 1 BID
Week1 PM dose;n=3,7,3
|
0.21171 Per hour
Geometric Coefficient of Variation 23.1
|
0.14307 Per hour
Geometric Coefficient of Variation 36.6
|
0.18789 Per hour
Geometric Coefficient of Variation 25.2
|
—
|
—
|
—
|
—
|
—
|
|
Lambda z for GSK525762-Part 1 BID
Week3 AM dose;n=3,7,3
|
0.23565 Per hour
Geometric Coefficient of Variation 27.2
|
0.21751 Per hour
Geometric Coefficient of Variation 27.7
|
0.30868 Per hour
Geometric Coefficient of Variation 19.6
|
—
|
—
|
—
|
—
|
—
|
|
Lambda z for GSK525762-Part 1 BID
Week3 PM dose;n=3,5,3
|
0.20507 Per hour
Geometric Coefficient of Variation 21.5
|
0.19263 Per hour
Geometric Coefficient of Variation 27.7
|
0.29133 Per hour
Geometric Coefficient of Variation 15.8
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4Population: PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=4 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Tmax for GSK525762-Part 1 BID
Week1 AM dose;n=4,10,5
|
1.5500 Hour
Interval 0.583 to 4.283
|
0.9667 Hour
Interval 0.55 to 2.1
|
0.5500 Hour
Interval 0.517 to 1.033
|
—
|
—
|
—
|
—
|
—
|
|
Tmax for GSK525762-Part 1 BID
Week1 PM dose;n=4,9,5
|
1.9583 Hour
Interval 1.917 to 4.0
|
1.9667 Hour
Interval 0.967 to 4.167
|
1.9833 Hour
Interval 1.017 to 7.733
|
—
|
—
|
—
|
—
|
—
|
|
Tmax for GSK525762-Part 1 BID
Week3 AM dose;n=3,7,3
|
1.1833 Hour
Interval 1.167 to 2.067
|
1.0667 Hour
Interval 0.25 to 2.017
|
0.5833 Hour
Interval 0.183 to 1.0
|
—
|
—
|
—
|
—
|
—
|
|
Tmax for GSK525762-Part 1 BID
Week3 PM dose;n=3,6,3
|
1.0000 Hour
Interval 0.5 to 2.083
|
1.4500 Hour
Interval 0.0 to 2.083
|
2.0667 Hour
Interval 1.9 to 2.067
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4Population: PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=4 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Clearance of GSK525762-Part 1 BID
Week1 AM dose;n=3,10,5
|
23.246 Liter per hour
Geometric Coefficient of Variation 124.4
|
9.621 Liter per hour
Geometric Coefficient of Variation 45.3
|
14.155 Liter per hour
Geometric Coefficient of Variation 32.8
|
—
|
—
|
—
|
—
|
—
|
|
Apparent Clearance of GSK525762-Part 1 BID
Week1 PM dose;n=4,7,5
|
21.745 Liter per hour
Geometric Coefficient of Variation 82.7
|
11.057 Liter per hour
Geometric Coefficient of Variation 48.1
|
16.382 Liter per hour
Geometric Coefficient of Variation 34.6
|
—
|
—
|
—
|
—
|
—
|
|
Apparent Clearance of GSK525762-Part 1 BID
Week3 AM dose;n=3,7,3
|
16.731 Liter per hour
Geometric Coefficient of Variation 110.1
|
11.949 Liter per hour
Geometric Coefficient of Variation 86.1
|
34.623 Liter per hour
Geometric Coefficient of Variation 18.7
|
—
|
—
|
—
|
—
|
—
|
|
Apparent Clearance of GSK525762-Part 1 BID
Week3 PM dose;n=3,5,3
|
18.867 Liter per hour
Geometric Coefficient of Variation 96.0
|
20.133 Liter per hour
Geometric Coefficient of Variation 26.2
|
37.097 Liter per hour
Geometric Coefficient of Variation 29.4
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4Population: PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.
Outcome measures
| Measure |
Part 1: GSK525762 20 mg BID
n=4 Participants
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 Participants
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=5 Participants
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution of GSK525762-Part 1 BID
Week1 AM dose;n=3,10,5
|
99.07 Liters
Geometric Coefficient of Variation 91.0
|
48.13 Liters
Geometric Coefficient of Variation 40.8
|
59.67 Liters
Geometric Coefficient of Variation 35.0
|
—
|
—
|
—
|
—
|
—
|
|
Volume of Distribution of GSK525762-Part 1 BID
Week1 PM dose;n=3,7,3
|
116.52 Liters
Geometric Coefficient of Variation 66.0
|
77.28 Liters
Geometric Coefficient of Variation 16.6
|
81.11 Liters
Geometric Coefficient of Variation 52.6
|
—
|
—
|
—
|
—
|
—
|
|
Volume of Distribution of GSK525762-Part 1 BID
Week3 AM dose;n=3,7,3
|
71.00 Liters
Geometric Coefficient of Variation 72.8
|
54.94 Liters
Geometric Coefficient of Variation 61.4
|
112.17 Liters
Geometric Coefficient of Variation 37.6
|
—
|
—
|
—
|
—
|
—
|
|
Volume of Distribution of GSK525762-Part 1 BID
Week3 PM dose;n=3,5,3
|
92.00 Liters
Geometric Coefficient of Variation 65.3
|
104.52 Liters
Geometric Coefficient of Variation 29.5
|
127.34 Liters
Geometric Coefficient of Variation 41.7
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part1: GSK525762 4 mg QD
Serious events: 2 serious events
Other events: 4 other events
Deaths: 4 deaths
Part 1: GSK525762 8 mg QD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Part 1: GSK525762 16 mg QD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Part 1: GSK525762 30 mg QD
Serious events: 1 serious events
Other events: 3 other events
Deaths: 4 deaths
Part 1: GSK525762 60 mg QD
Serious events: 2 serious events
Other events: 9 other events
Deaths: 7 deaths
Part 1: GSK525762 80 mg QD
Serious events: 21 serious events
Other events: 31 other events
Deaths: 30 deaths
Part 1: GSK525762 100 mg QD
Serious events: 3 serious events
Other events: 9 other events
Deaths: 7 deaths
Part 1: GSK525762 20 mg BID
Serious events: 0 serious events
Other events: 4 other events
Deaths: 1 deaths
Part 1: GSK525762 30 mg BID
Serious events: 4 serious events
Other events: 10 other events
Deaths: 9 deaths
Part 1: GSK525762 40 mg BID
Serious events: 2 serious events
Other events: 5 other events
Deaths: 3 deaths
Part 2: Participants With NMC
Serious events: 6 serious events
Other events: 11 other events
Deaths: 8 deaths
Part 2: Participants With SCLC
Serious events: 9 serious events
Other events: 14 other events
Deaths: 12 deaths
Part 2: Participants With CRPC
Serious events: 16 serious events
Other events: 23 other events
Deaths: 21 deaths
Part1: GSK525762 2 mg QD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Part 2: Participants With TNBC
Serious events: 11 serious events
Other events: 19 other events
Deaths: 16 deaths
Part 2: Participants With ER+BC
Serious events: 15 serious events
Other events: 21 other events
Deaths: 17 deaths
Part 2: Participants With GIST
Serious events: 8 serious events
Other events: 12 other events
Deaths: 5 deaths
80mg Amor+6mg Iso/80mg Bes+6mg
Serious events: 3 serious events
Other events: 5 other events
Deaths: 1 deaths
80mg Bes+6mg Iso/80mg Amor+6mg
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part1: GSK525762 4 mg QD
n=4 participants at risk
Participants were administered once daily oral dose of 4 mg GSK525762.
|
Part 1: GSK525762 8 mg QD
n=1 participants at risk
Participants were administered once daily oral dose of 8 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=3 participants at risk
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=4 participants at risk
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=9 participants at risk
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=32 participants at risk
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
n=9 participants at risk
Participants were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 20 mg BID
n=4 participants at risk
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 participants at risk
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=5 participants at risk
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 2: Participants With NMC
n=12 participants at risk
Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762.
|
Part 2: Participants With SCLC
n=14 participants at risk
Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762.
|
Part 2: Participants With CRPC
n=23 participants at risk
Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762.
|
Part1: GSK525762 2 mg QD
n=3 participants at risk
Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.
|
Part 2: Participants With TNBC
n=19 participants at risk
Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762.
|
Part 2: Participants With ER+BC
n=21 participants at risk
Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762.
|
Part 2: Participants With GIST
n=13 participants at risk
Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762.
|
80mg Amor+6mg Iso/80mg Bes+6mg
n=5 participants at risk
Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.
|
80mg Bes+6mg Iso/80mg Amor+6mg
n=5 participants at risk
Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.5%
2/21 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Amylase increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
6.2%
2/32 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
16.7%
2/12 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
13.0%
3/23 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Asthenia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
6.2%
2/32 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.5%
2/21 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Cardiac disorders
Cardiotoxicity
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Chest pain
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Coagulation factor VII level decreased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
40.0%
2/5 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.5%
2/21 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Psychiatric disorders
Confusional state
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
6.2%
2/32 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Device related infection
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.5%
2/21 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
General physical health deterioration
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
6.2%
2/32 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
13.0%
3/23 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Blood and lymphatic system disorders
Histiocytosis haematophagic
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
2/10 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Infection
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Lipase increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Malaise
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
12.5%
4/32 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
13.0%
3/23 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.5%
2/19 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Pain
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus haemorrhage
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Sudden death
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
8/32 • Number of events 10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
22.2%
2/9 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
3/12 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
28.6%
4/14 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
39.1%
9/23 • Number of events 10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
21.1%
4/19 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.5%
2/21 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
60.0%
3/5 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Cardiac disorders
Thyrotoxic cardiomyopathy
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Troponin I increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.7%
2/23 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.4%
3/32 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
17.4%
4/23 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
Other adverse events
| Measure |
Part1: GSK525762 4 mg QD
n=4 participants at risk
Participants were administered once daily oral dose of 4 mg GSK525762.
|
Part 1: GSK525762 8 mg QD
n=1 participants at risk
Participants were administered once daily oral dose of 8 mg GSK525762.
|
Part 1: GSK525762 16 mg QD
n=3 participants at risk
Participants were administered once daily oral dose of 16 mg GSK525762.
|
Part 1: GSK525762 30 mg QD
n=4 participants at risk
Participants were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 60 mg QD
n=9 participants at risk
Participants were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=32 participants at risk
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD
n=9 participants at risk
Participants were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 20 mg BID
n=4 participants at risk
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg BID
n=10 participants at risk
Participants were administered twice daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg BID
n=5 participants at risk
Participants were administered twice daily oral dose of 40 mg GSK525762.
|
Part 2: Participants With NMC
n=12 participants at risk
Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762.
|
Part 2: Participants With SCLC
n=14 participants at risk
Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762.
|
Part 2: Participants With CRPC
n=23 participants at risk
Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762.
|
Part1: GSK525762 2 mg QD
n=3 participants at risk
Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.
|
Part 2: Participants With TNBC
n=19 participants at risk
Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762.
|
Part 2: Participants With ER+BC
n=21 participants at risk
Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762.
|
Part 2: Participants With GIST
n=13 participants at risk
Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762.
|
80mg Amor+6mg Iso/80mg Bes+6mg
n=5 participants at risk
Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.
|
80mg Bes+6mg Iso/80mg Amor+6mg
n=5 participants at risk
Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Blood albumin increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
100.0%
1/1 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
12.5%
4/32 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
2/10 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
40.0%
2/5 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
15.4%
2/13 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
16.7%
2/12 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
23.8%
5/21 • Number of events 6 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
40.0%
2/5 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
6.2%
2/32 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
14.3%
3/21 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
80.0%
4/5 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.4%
3/32 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
100.0%
1/1 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
12.5%
4/32 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
22.2%
2/9 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
14.3%
2/14 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
13.0%
3/23 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
21.1%
4/19 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
19.0%
4/21 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Amylase increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.7%
2/23 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
34.4%
11/32 • Number of events 14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
55.6%
5/9 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
50.0%
2/4 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
40.0%
4/10 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
3/12 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
42.9%
6/14 • Number of events 6 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
56.5%
13/23 • Number of events 14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
36.8%
7/19 • Number of events 7 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
42.9%
9/21 • Number of events 11 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
15.4%
2/13 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
80.0%
4/5 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
60.0%
3/5 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Anal inflammation
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Angular cheilitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Psychiatric disorders
Anhedonia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
6.2%
2/32 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
66.7%
2/3 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
40.0%
2/5 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.4%
3/32 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
16.7%
2/12 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
100.0%
1/1 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
15.6%
5/32 • Number of events 6 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
22.2%
2/9 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
16.7%
2/12 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
14.3%
2/14 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
26.1%
6/23 • Number of events 8 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
21.1%
4/19 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
28.6%
6/21 • Number of events 7 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
15.4%
2/13 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
40.0%
2/5 • Number of events 6 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Asthenia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
31.2%
10/32 • Number of events 13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
70.0%
7/10 • Number of events 8 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
60.0%
3/5 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
41.7%
5/12 • Number of events 6 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
28.6%
4/14 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
26.1%
6/23 • Number of events 6 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
36.8%
7/19 • Number of events 9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
52.4%
11/21 • Number of events 12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
23.1%
3/13 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Axillary pain
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
12.5%
4/32 • Number of events 6 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
17.4%
4/23 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.5%
2/21 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Bacterial test positive
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
22.2%
2/9 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
14.3%
3/21 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Blood bilirubin unconjugated increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Blood chloride decreased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Blood creatine phosphokinase MB increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
14.3%
3/21 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
38.5%
5/13 • Number of events 6 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.4%
3/32 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
16.7%
2/12 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
21.4%
3/14 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
13.0%
3/23 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
19.0%
4/21 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Blood insulin increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
16.7%
2/12 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.5%
2/19 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.5%
2/21 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
16.7%
2/12 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Eye disorders
Cataract
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Catheter site inflammation
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Catheter site pain
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Chest discomfort
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Chest pain
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
16.7%
2/12 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Chills
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.5%
2/21 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Coagulation factor VII level decreased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
30.0%
3/10 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
15.8%
3/19 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
19.0%
4/21 • Number of events 6 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
23.1%
3/13 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Musculoskeletal and connective tissue disorders
Connective tissue disorder
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Constipation
|
75.0%
3/4 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
22.2%
2/9 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
3/9 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
2/10 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
3/12 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
21.7%
5/23 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
26.3%
5/19 • Number of events 6 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
15.4%
2/13 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
80.0%
4/5 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
6.2%
2/32 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
3/12 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
21.7%
5/23 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
40.0%
2/5 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
3/9 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
12.5%
4/32 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
30.0%
3/10 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
3/12 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.7%
2/23 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.5%
2/21 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Cystitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
2/4 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
22.2%
2/9 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
46.9%
15/32 • Number of events 19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
66.7%
6/9 • Number of events 8 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
70.0%
7/10 • Number of events 10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
80.0%
4/5 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
4/12 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
35.7%
5/14 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
65.2%
15/23 • Number of events 16 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
42.1%
8/19 • Number of events 8 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
47.6%
10/21 • Number of events 11 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
46.2%
6/13 • Number of events 6 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
40.0%
2/5 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
6.2%
2/32 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
22.2%
2/9 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
21.4%
3/14 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.7%
2/23 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.5%
2/21 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Psychiatric disorders
Delirium
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Psychiatric disorders
Depression
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
22.2%
2/9 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.4%
3/32 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.5%
2/21 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Device related infection
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
2/10 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
34.4%
11/32 • Number of events 16 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
44.4%
4/9 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
60.0%
6/10 • Number of events 10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
100.0%
5/5 • Number of events 8 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
50.0%
6/12 • Number of events 8 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
28.6%
4/14 • Number of events 6 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
52.2%
12/23 • Number of events 24 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
36.8%
7/19 • Number of events 7 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
38.1%
8/21 • Number of events 11 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
30.8%
4/13 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
60.0%
3/5 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Eye disorders
Diplopia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.4%
3/32 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
22.2%
2/9 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
19.0%
4/21 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Nervous system disorders
Drug withdrawal headache
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
66.7%
2/3 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
50.0%
2/4 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.4%
3/32 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
30.0%
3/10 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
16.7%
2/12 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
13.0%
3/23 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
14.3%
3/21 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
6.2%
2/32 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
2/10 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
15.8%
3/19 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
3/9 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
8/32 • Number of events 9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
55.6%
5/9 • Number of events 6 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
40.0%
4/10 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
40.0%
2/5 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
4/12 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
14.3%
2/14 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
43.5%
10/23 • Number of events 12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
26.3%
5/19 • Number of events 6 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
7/21 • Number of events 8 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
38.5%
5/13 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
40.0%
2/5 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
60.0%
3/5 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.5%
2/21 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
15.6%
5/32 • Number of events 7 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
55.6%
5/9 • Number of events 6 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
30.0%
3/10 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
16.7%
2/12 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
28.6%
4/14 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
21.7%
5/23 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
21.1%
4/19 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
38.1%
8/21 • Number of events 8 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
30.8%
4/13 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
40.0%
2/5 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.7%
2/23 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.4%
3/32 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.7%
2/23 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Ear infection
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.5%
2/21 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Electrocardiogram QRS complex prolonged
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
22.2%
2/9 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Endometritis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
15.6%
5/32 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
22.2%
2/9 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
41.7%
5/12 • Number of events 6 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
26.1%
6/23 • Number of events 6 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Face oedema
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
15.8%
3/19 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Facial pain
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Congenital, familial and genetic disorders
Factor V deficiency
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
3/9 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
34.4%
11/32 • Number of events 12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
55.6%
5/9 • Number of events 6 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
4/12 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
35.7%
5/14 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
52.2%
12/23 • Number of events 15 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
36.8%
7/19 • Number of events 7 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
19.0%
4/21 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
23.1%
3/13 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
60.0%
3/5 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
60.0%
3/5 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Flatulence
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Injury, poisoning and procedural complications
Genital contusion
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Genital herpes simplex
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
6.2%
2/32 • Number of events 6 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Guttate psoriasis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Vascular disorders
Haematoma
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.5%
2/21 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
30.4%
7/23 • Number of events 10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
6.2%
2/32 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.7%
2/23 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Psychiatric disorders
Hallucination
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.4%
3/32 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
3/12 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
21.1%
4/19 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.5%
2/21 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
23.1%
3/13 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Herpes dermatitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.5%
2/21 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
28.1%
9/32 • Number of events 11 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
55.6%
5/9 • Number of events 6 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
40.0%
4/10 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
40.0%
2/5 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
50.0%
6/12 • Number of events 8 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
28.6%
4/14 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
30.4%
7/23 • Number of events 9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.5%
2/19 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
42.9%
9/21 • Number of events 12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
15.4%
2/13 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
40.0%
2/5 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
40.0%
2/5 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
6.2%
2/32 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.5%
2/21 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
100.0%
1/1 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
18.8%
6/32 • Number of events 6 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
40.0%
4/10 • Number of events 7 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
16.7%
2/12 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.7%
2/23 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
15.8%
3/19 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
28.6%
6/21 • Number of events 7 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
38.5%
5/13 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
40.0%
2/5 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
6.2%
2/32 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
6.2%
2/32 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
50.0%
2/4 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
6.2%
2/32 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
2/10 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
15.8%
3/19 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.5%
2/21 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
40.0%
2/5 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
6.2%
2/32 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Metabolism and nutrition disorders
Hypocholesterolaemia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
15.6%
5/32 • Number of events 6 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
40.0%
4/10 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
14.3%
2/14 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
13.0%
3/23 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
50.0%
2/4 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
100.0%
1/1 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
40.0%
2/5 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
12.5%
4/32 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.5%
2/19 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.5%
2/21 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
40.0%
2/5 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Infected cyst
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Infection
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.5%
2/19 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
19.0%
4/21 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
40.0%
2/5 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
21.9%
7/32 • Number of events 7 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
22.2%
2/9 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
4/12 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
21.7%
5/23 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
15.8%
3/19 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
19.0%
4/21 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
30.8%
4/13 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
80.0%
4/5 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Eye disorders
Keratitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
6.2%
2/32 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
60.0%
3/5 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Leukoplakia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Lip infection
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Lipase increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
6.2%
2/32 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
14.3%
2/14 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.7%
2/23 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
15.4%
2/13 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Localised oedema
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Lung infection
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
12.5%
4/32 • Number of events 7 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
2/10 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
13.0%
3/23 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.5%
2/19 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Madarosis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Malaise
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.5%
2/21 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.4%
3/32 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.7%
2/23 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
13.0%
3/23 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
14.3%
3/21 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.4%
3/32 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.5%
2/21 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
17.4%
4/23 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
15.8%
3/19 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
N-terminal prohormone brain natriuretic peptide increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Nail infection
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
100.0%
1/1 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
75.0%
3/4 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
22.2%
2/9 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
46.9%
15/32 • Number of events 19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
77.8%
7/9 • Number of events 10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
50.0%
2/4 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
60.0%
6/10 • Number of events 9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
41.7%
5/12 • Number of events 6 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
57.1%
8/14 • Number of events 8 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
47.8%
11/23 • Number of events 16 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
42.1%
8/19 • Number of events 12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
42.9%
9/21 • Number of events 12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
38.5%
5/13 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
60.0%
3/5 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
6.2%
2/32 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
16.7%
2/12 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
21.4%
3/14 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
19.0%
4/21 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Nocturnal dyspnoea
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Cardiac disorders
Nodal rhythm
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.4%
3/32 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Occult blood positive
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
6.2%
2/32 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
13.0%
3/23 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
15.8%
3/19 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.5%
2/21 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Eye disorders
Optic neuropathy
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
6.2%
2/32 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.4%
3/32 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Eye disorders
Orbital oedema
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Otitis media
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Pain
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
6.2%
2/32 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Perianal erythema
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Protein urine present
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
12.5%
4/32 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
30.0%
3/10 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
40.0%
2/5 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
3/12 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
17.4%
4/23 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.5%
2/19 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
19.0%
4/21 • Number of events 7 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
30.8%
4/13 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
40.0%
2/5 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Prothrombin time ratio decreased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
6.2%
2/32 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
21.4%
3/14 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
21.1%
4/19 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
18.8%
6/32 • Number of events 8 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
2/10 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
28.6%
4/14 • Number of events 6 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
21.1%
4/19 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.5%
2/21 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
22.2%
2/9 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
15.6%
5/32 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
22.2%
2/9 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
2/10 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
41.7%
5/12 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
28.6%
4/14 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
14.3%
3/21 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
14.3%
2/14 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
6.2%
2/32 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Skin candida
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Nervous system disorders
Somnolence
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.4%
3/32 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
6.2%
2/32 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
30.0%
3/10 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
14.3%
2/14 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
14.3%
3/21 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
6.2%
2/32 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
2/10 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Throat clearing
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
22.2%
2/9 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
56.2%
18/32 • Number of events 39 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
55.6%
5/9 • Number of events 8 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
70.0%
7/10 • Number of events 8 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
100.0%
5/5 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
3/12 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
50.0%
7/14 • Number of events 12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
52.2%
12/23 • Number of events 23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
68.4%
13/19 • Number of events 15 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
61.9%
13/21 • Number of events 18 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
23.1%
3/13 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
80.0%
4/5 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
60.0%
3/5 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Thyroxine free decreased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Thyroxine free increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.7%
2/23 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Transaminases increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Nervous system disorders
Tremor
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Tri-iodothyronine free decreased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Troponin T increased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.7%
2/23 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.5%
2/19 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
1/3 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.4%
3/32 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.1%
1/14 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
17.4%
4/23 • Number of events 7 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
15.8%
3/19 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.3%
1/23 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Reproductive system and breast disorders
Vaginal odour
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
3.1%
1/32 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.3%
1/12 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
5.3%
1/19 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.4%
3/32 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
11.1%
1/9 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
66.7%
2/3 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
1/4 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
22.2%
2/9 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
34.4%
11/32 • Number of events 20 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
44.4%
4/9 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
75.0%
3/4 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
30.0%
3/10 • Number of events 6 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
33.3%
4/12 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
28.6%
4/14 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
39.1%
9/23 • Number of events 18 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
42.1%
8/19 • Number of events 11 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
28.6%
6/21 • Number of events 8 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
15.4%
2/13 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
60.0%
3/5 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
7.7%
1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
9.4%
3/32 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
44.4%
4/9 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
30.0%
3/10 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
25.0%
3/12 • Number of events 4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
8.7%
2/23 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.5%
2/19 • Number of events 3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
23.8%
5/21 • Number of events 5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
15.4%
2/13 • Number of events 2 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
20.0%
1/5 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/10 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
4.8%
1/21 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
|
General disorders
Xerosis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/32 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/9 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/4 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
10.0%
1/10 • Number of events 1 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/12 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/14 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/23 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/3 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/19 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/21 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/13 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
0.00%
0/5 • Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse events were collected in the All Treated Population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER