Trial Outcomes & Findings for Study of Safety and Proof of the Mechanism of BLZ945 in ALS Patients (NCT NCT04066244)
NCT ID: NCT04066244
Last Updated: 2025-10-16
Results Overview
\[11C\]-PBR28 is a positron emission tomography (PET) radiotracer for the 18 kDa translocator protein (TSPO) that is used to image neuroinflammation in vivo. \[11C\]PBR28 imaging was used to measure microglial volume at baseline and after BLZ945 treatment in ALS participants. Relative % change from baseline in volume of distribution (Vt) of \[11C\]-PBR28 in different brain regions after BLZ945 treatment
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Baseline, day 5
Results posted on
2025-10-16
Participant Flow
There was a screening and baseline period of up to 42 days for part 1 (Cohorts1-4) and of 6 weeks for part 2 (Cohort 5)
Participant milestones
| Measure |
BLZ945 300mg - Cohort 1 (Part 1)
BLZ945 300mg
|
BLZ945 600mg - Cohort 2 (Part 1)
BLZ945 600mg
|
BLZ945 800mg - Cohort 4 (Part 1)
BLZ945 800mg
|
BLZ945 1200mg - Cohort 3 (Part 1)
BLZ945 1200mg
|
BLZ945 800mg - Cohort 5 Arm #1 (Part 2)
BLZ945 800mg (4 days on/10 days off)
|
BLZ945 800mg - Cohort 5 Arm #2 (Part 2)
BLZ945 800mg (once weekly)
|
|---|---|---|---|---|---|---|
|
Part 1 (Cohort 1-4)
STARTED
|
4
|
4
|
4
|
4
|
0
|
0
|
|
Part 1 (Cohort 1-4)
COMPLETED
|
4
|
4
|
4
|
4
|
0
|
0
|
|
Part 1 (Cohort 1-4)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 (Cohort 5)
STARTED
|
0
|
0
|
0
|
0
|
6
|
6
|
|
Part 2 (Cohort 5)
COMPLETED
|
0
|
0
|
0
|
0
|
5
|
2
|
|
Part 2 (Cohort 5)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
4
|
Reasons for withdrawal
| Measure |
BLZ945 300mg - Cohort 1 (Part 1)
BLZ945 300mg
|
BLZ945 600mg - Cohort 2 (Part 1)
BLZ945 600mg
|
BLZ945 800mg - Cohort 4 (Part 1)
BLZ945 800mg
|
BLZ945 1200mg - Cohort 3 (Part 1)
BLZ945 1200mg
|
BLZ945 800mg - Cohort 5 Arm #1 (Part 2)
BLZ945 800mg (4 days on/10 days off)
|
BLZ945 800mg - Cohort 5 Arm #2 (Part 2)
BLZ945 800mg (once weekly)
|
|---|---|---|---|---|---|---|
|
Part 2 (Cohort 5)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part 2 (Cohort 5)
Death
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Part 2 (Cohort 5)
Study terminated by sponsor
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part 2 (Cohort 5)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study of Safety and Proof of the Mechanism of BLZ945 in ALS Patients
Baseline characteristics by cohort
| Measure |
BLZ945 300mg - Cohort 1 (Part 1)
n=4 Participants
BLZ945 300mg
|
BLZ945 600mg - Cohort 2 (Part 1)
n=4 Participants
BLZ945 600mg
|
BLZ945 800mg - Cohort 4 (Part 1)
n=4 Participants
BLZ945 800mg
|
BLZ945 1200mg - Cohort 3 (Part 1)
n=4 Participants
BLZ945 1200mg
|
BLZ945 800mg - Cohort 5 Arm #1 (Part 2)
n=6 Participants
BLZ945 800mg (4 days on/10 days off)
|
BLZ945 800mg - Cohort 5 Arm #2 (Part 2)
n=6 Participants
BLZ945 800mg (once weekly)
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
50.5 years
n=5 Participants
|
59.5 years
n=7 Participants
|
65.5 years
n=5 Participants
|
64 years
n=4 Participants
|
55.5 years
n=21 Participants
|
62.5 years
n=10 Participants
|
60.5 years
n=115 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
27 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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=10 Participants
|
1 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline, day 5Population: PD analysis set, all participants in cohorts 1-4 with available PD data and no protocol deviations with relevant impact on PD data and with a valid assessment of the outcome measure.
\[11C\]-PBR28 is a positron emission tomography (PET) radiotracer for the 18 kDa translocator protein (TSPO) that is used to image neuroinflammation in vivo. \[11C\]PBR28 imaging was used to measure microglial volume at baseline and after BLZ945 treatment in ALS participants. Relative % change from baseline in volume of distribution (Vt) of \[11C\]-PBR28 in different brain regions after BLZ945 treatment
Outcome measures
| Measure |
BLZ945 300mg - Cohort 1 (Part 1)
n=3 Participants
BLZ945 300mg
|
BLZ945 600mg - Cohort 2 (Part 1)
n=3 Participants
BLZ945 600mg
|
BLZ945 800mg - Cohort 4 (Part 1)
n=4 Participants
BLZ945 800mg
|
BLZ945 1200mg - Cohort 3 (Part 1)
n=2 Participants
BLZ945 1200mg
|
BLZ945 800mg - Cohort 5 Arm #1 (Part 2)
BLZ945 800mg (4 days on/10 days off)
|
BLZ945 800mg - Cohort 5 Arm #2 (Part 2)
BLZ945 800mg (once weekly)
|
|---|---|---|---|---|---|---|
|
Cohorts 1-4 : Change From Baseline in Volume of Distribution (Vt) in Different Brain Regions for [11C]-PBR28 PET Scan
Precentral gyrus - day 5
|
0.67 Percent change from baseline
Standard Deviation 33.825
|
-20.33 Percent change from baseline
Standard Deviation 16.458
|
9.90 Percent change from baseline
Standard Deviation 31.570
|
-9.63 Percent change from baseline
Standard Deviation 1.516
|
—
|
—
|
|
Cohorts 1-4 : Change From Baseline in Volume of Distribution (Vt) in Different Brain Regions for [11C]-PBR28 PET Scan
Basal Ganglia - day 5
|
-3.70 Percent change from baseline
Standard Deviation 22.729
|
-15.18 Percent change from baseline
Standard Deviation 16.343
|
13.27 Percent change from baseline
Standard Deviation 35.504
|
-10.73 Percent change from baseline
Standard Deviation 5.872
|
—
|
—
|
|
Cohorts 1-4 : Change From Baseline in Volume of Distribution (Vt) in Different Brain Regions for [11C]-PBR28 PET Scan
Brain Stem - day 5
|
-7.10 Percent change from baseline
Standard Deviation 20.890
|
-10.00 Percent change from baseline
Standard Deviation 13.464
|
50.56 Percent change from baseline
Standard Deviation 100.838
|
-16.69 Percent change from baseline
Standard Deviation 61.674
|
—
|
—
|
|
Cohorts 1-4 : Change From Baseline in Volume of Distribution (Vt) in Different Brain Regions for [11C]-PBR28 PET Scan
Cerebellar White Matter - day 5
|
-4.41 Percent change from baseline
Standard Deviation 20.678
|
-14.11 Percent change from baseline
Standard Deviation 11.904
|
27.65 Percent change from baseline
Standard Deviation 60.112
|
-16.87 Percent change from baseline
Standard Deviation 4.874
|
—
|
—
|
|
Cohorts 1-4 : Change From Baseline in Volume of Distribution (Vt) in Different Brain Regions for [11C]-PBR28 PET Scan
Cerebellum - day 5
|
-3.53 Percent change from baseline
Standard Deviation 20.459
|
-10.06 Percent change from baseline
Standard Deviation 8.365
|
17.52 Percent change from baseline
Standard Deviation 44.628
|
-11.78 Percent change from baseline
Standard Deviation 3.854
|
—
|
—
|
|
Cohorts 1-4 : Change From Baseline in Volume of Distribution (Vt) in Different Brain Regions for [11C]-PBR28 PET Scan
Frontal Lobe - day 5
|
1.33 Percent change from baseline
Standard Deviation 30.101
|
-18.67 Percent change from baseline
Standard Deviation 15.881
|
9.10 Percent change from baseline
Standard Deviation 29.745
|
-9.70 Percent change from baseline
Standard Deviation 0.224
|
—
|
—
|
|
Cohorts 1-4 : Change From Baseline in Volume of Distribution (Vt) in Different Brain Regions for [11C]-PBR28 PET Scan
Occipital Lobe - day 5
|
-3.01 Percent change from baseline
Standard Deviation 23.217
|
-11.50 Percent change from baseline
Standard Deviation 10.457
|
14.18 Percent change from baseline
Standard Deviation 36.595
|
-5.87 Percent change from baseline
Standard Deviation 0.292
|
—
|
—
|
|
Cohorts 1-4 : Change From Baseline in Volume of Distribution (Vt) in Different Brain Regions for [11C]-PBR28 PET Scan
Thalamus - day 5
|
-8.00 Percent change from baseline
Standard Deviation 22.581
|
-14.85 Percent change from baseline
Standard Deviation 13.466
|
13.89 Percent change from baseline
Standard Deviation 42.938
|
-14.14 Percent change from baseline
Standard Deviation 3.521
|
—
|
—
|
|
Cohorts 1-4 : Change From Baseline in Volume of Distribution (Vt) in Different Brain Regions for [11C]-PBR28 PET Scan
Whole Brain - day 5
|
-0.95 Percent change from baseline
Standard Deviation 26.606
|
-15.59 Percent change from baseline
Standard Deviation 14.716
|
12.22 Percent change from baseline
Standard Deviation 34.922
|
-7.72 Percent change from baseline
Standard Deviation 0.326
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, day 84Population: PD analysis set, all participants in cohort 5 with available PD data and no protocol deviations with relevant impact on PD data and with a valid assessment of the outcome measure.
\[11C\]-PBR28 is a positron emission tomography (PET) radiotracer for the 18 kDa translocator protein (TSPO) that is used to image neuroinflammation in vivo. \[11C\]PBR28 imaging was used to measure microglial volume at baseline and after BLZ945 treatment in ALS participants. Relative % change from baseline in volume of distribution (Vt) of \[11C\]-PBR28 in different brain regions after BLZ945 treatment
Outcome measures
| Measure |
BLZ945 300mg - Cohort 1 (Part 1)
n=1 Participants
BLZ945 300mg
|
BLZ945 600mg - Cohort 2 (Part 1)
BLZ945 600mg
|
BLZ945 800mg - Cohort 4 (Part 1)
BLZ945 800mg
|
BLZ945 1200mg - Cohort 3 (Part 1)
BLZ945 1200mg
|
BLZ945 800mg - Cohort 5 Arm #1 (Part 2)
BLZ945 800mg (4 days on/10 days off)
|
BLZ945 800mg - Cohort 5 Arm #2 (Part 2)
BLZ945 800mg (once weekly)
|
|---|---|---|---|---|---|---|
|
Cohort 5 (PET Sub-study): Change From Baseline in Volume of Distribution (Vt) in Different Brain Regions for [11C]-PBR28 PET Scan
Precentral gyrus - day 84
|
-21.95 Percent change from baseline
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 5 (PET Sub-study): Change From Baseline in Volume of Distribution (Vt) in Different Brain Regions for [11C]-PBR28 PET Scan
Basal Ganglia - day 84
|
-17.80 Percent change from baseline
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 5 (PET Sub-study): Change From Baseline in Volume of Distribution (Vt) in Different Brain Regions for [11C]-PBR28 PET Scan
Brain Stem - day 84
|
-26.10 Percent change from baseline
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 5 (PET Sub-study): Change From Baseline in Volume of Distribution (Vt) in Different Brain Regions for [11C]-PBR28 PET Scan
Cerebellar White Matter - day 84
|
-22.40 Percent change from baseline
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 5 (PET Sub-study): Change From Baseline in Volume of Distribution (Vt) in Different Brain Regions for [11C]-PBR28 PET Scan
Cerebellum - day 84
|
-19.40 Percent change from baseline
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 5 (PET Sub-study): Change From Baseline in Volume of Distribution (Vt) in Different Brain Regions for [11C]-PBR28 PET Scan
Frontal Lobe - day 84
|
-21.53 Percent change from baseline
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 5 (PET Sub-study): Change From Baseline in Volume of Distribution (Vt) in Different Brain Regions for [11C]-PBR28 PET Scan
Occipital Lobe - day 84
|
-17.76 Percent change from baseline
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 5 (PET Sub-study): Change From Baseline in Volume of Distribution (Vt) in Different Brain Regions for [11C]-PBR28 PET Scan
Thalamus - day 84
|
-29.39 Percent change from baseline
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 5 (PET Sub-study): Change From Baseline in Volume of Distribution (Vt) in Different Brain Regions for [11C]-PBR28 PET Scan
Whole Brain - day 84
|
-20.51 Percent change from baseline
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 84Population: Full analysis set, participants in cohort 5 that received any study drug with a valid assessment for the outcome measure
Mean change from baseline in esophageal wall thickness measured in mm
Outcome measures
| Measure |
BLZ945 300mg - Cohort 1 (Part 1)
n=4 Participants
BLZ945 300mg
|
BLZ945 600mg - Cohort 2 (Part 1)
n=2 Participants
BLZ945 600mg
|
BLZ945 800mg - Cohort 4 (Part 1)
BLZ945 800mg
|
BLZ945 1200mg - Cohort 3 (Part 1)
BLZ945 1200mg
|
BLZ945 800mg - Cohort 5 Arm #1 (Part 2)
BLZ945 800mg (4 days on/10 days off)
|
BLZ945 800mg - Cohort 5 Arm #2 (Part 2)
BLZ945 800mg (once weekly)
|
|---|---|---|---|---|---|---|
|
Cohort 5: Change From Baseline in Esophageal Wall Thickness
Wall thickness average
|
0.258 mm
Standard Deviation 0.7990
|
0.758 mm
Standard Deviation 2.1708
|
—
|
—
|
—
|
—
|
|
Cohort 5: Change From Baseline in Esophageal Wall Thickness
Lower third Wall Thickness
|
0.040 mm
Standard Deviation 0.9475
|
-1.400 mm
Standard Deviation 2.9981
|
—
|
—
|
—
|
—
|
|
Cohort 5: Change From Baseline in Esophageal Wall Thickness
Middle third Wall Thickness
|
0.235 mm
Standard Deviation 0.0212
|
2.795 mm
Standard Deviation 2.6234
|
—
|
—
|
—
|
—
|
|
Cohort 5: Change From Baseline in Esophageal Wall Thickness
Upper third Wall Thickness
|
0.500 mm
Standard Deviation 1.4284
|
0.880 mm
Standard Deviation 0.8910
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 84Population: Full analysis set, participants in cohort 5 that received any study drug with a valid assessment for the outcome measure
Cardiac valve thickness on a three point ordinal scale. Categorized by imaging vendor into three semiquantitative (normal, mild-moderate and severe) categories
Outcome measures
| Measure |
BLZ945 300mg - Cohort 1 (Part 1)
n=6 Participants
BLZ945 300mg
|
BLZ945 600mg - Cohort 2 (Part 1)
n=6 Participants
BLZ945 600mg
|
BLZ945 800mg - Cohort 4 (Part 1)
BLZ945 800mg
|
BLZ945 1200mg - Cohort 3 (Part 1)
BLZ945 1200mg
|
BLZ945 800mg - Cohort 5 Arm #1 (Part 2)
BLZ945 800mg (4 days on/10 days off)
|
BLZ945 800mg - Cohort 5 Arm #2 (Part 2)
BLZ945 800mg (once weekly)
|
|---|---|---|---|---|---|---|
|
Cohort 5: Cardiac Valve Thickness at Day 84 Compared to Baseline
Aortic valve thickness - Baseline · Normal
|
6 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Thickness at Day 84 Compared to Baseline
Aortic valve thickness - Baseline · Mild- Moderate
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Thickness at Day 84 Compared to Baseline
Aortic valve thickness - Day 84 · Normal
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Thickness at Day 84 Compared to Baseline
Aortic valve thickness - Day 84 · Mild- Moderate
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Thickness at Day 84 Compared to Baseline
Mitral valve thickness - Baseline · Normal
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Thickness at Day 84 Compared to Baseline
Mitral valve thickness - Baseline · Mild- Moderate
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Thickness at Day 84 Compared to Baseline
Mitral valve thickness - Day 84 · Normal
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Thickness at Day 84 Compared to Baseline
Mitral valve thickness - Day 84 · Mild- Moderate
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Thickness at Day 84 Compared to Baseline
Pulmonary valve thickness - Baseline · Normal
|
6 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Thickness at Day 84 Compared to Baseline
Pulmonary valve thickness - Baseline · Mild- Moderate
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Thickness at Day 84 Compared to Baseline
Pulmonary valve thickness - Day 84 · Normal
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Thickness at Day 84 Compared to Baseline
Pulmonary valve thickness - Day 84 · Mild- Moderate
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Thickness at Day 84 Compared to Baseline
Tricuspid valve thickness - Baseline · Normal
|
6 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Thickness at Day 84 Compared to Baseline
Tricuspid valve thickness - Baseline · Mild- Moderate
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Thickness at Day 84 Compared to Baseline
Tricuspid valve thickness - Day 84 · Normal
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Thickness at Day 84 Compared to Baseline
Tricuspid valve thickness - Day 84 · Mild- Moderate
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 84Population: Full analysis set, participants in cohort 5 that received any study drug with a valid assessment for the outcome measure
Cardiac valve stenosis on a four point ordinal scale. Categorized by imaging vendor into four semiquantitative (normal, mild, moderate and severe) categories
Outcome measures
| Measure |
BLZ945 300mg - Cohort 1 (Part 1)
n=6 Participants
BLZ945 300mg
|
BLZ945 600mg - Cohort 2 (Part 1)
n=6 Participants
BLZ945 600mg
|
BLZ945 800mg - Cohort 4 (Part 1)
BLZ945 800mg
|
BLZ945 1200mg - Cohort 3 (Part 1)
BLZ945 1200mg
|
BLZ945 800mg - Cohort 5 Arm #1 (Part 2)
BLZ945 800mg (4 days on/10 days off)
|
BLZ945 800mg - Cohort 5 Arm #2 (Part 2)
BLZ945 800mg (once weekly)
|
|---|---|---|---|---|---|---|
|
Cohort 5: Cardiac Valve Stenosis at Day 84 Compared to Baseline
Aortic valve - Baseline · Normal
|
6 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Stenosis at Day 84 Compared to Baseline
Aortic valve - Baseline · Mild
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Stenosis at Day 84 Compared to Baseline
Aortic valve - Day 84 · Normal
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Stenosis at Day 84 Compared to Baseline
Aortic valve - Day 84 · Mild
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Stenosis at Day 84 Compared to Baseline
Mitral valve - Baseline · Normal
|
6 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Stenosis at Day 84 Compared to Baseline
Mitral valve - Baseline · Mild
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Stenosis at Day 84 Compared to Baseline
Mitral valve - Day 84 · Normal
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Stenosis at Day 84 Compared to Baseline
Mitral valve - Day 84 · Mild
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Stenosis at Day 84 Compared to Baseline
Pulmonary valve - Baseline · Normal
|
6 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Stenosis at Day 84 Compared to Baseline
Pulmonary valve - Baseline · Mild
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Stenosis at Day 84 Compared to Baseline
Pulmonary valve thickness - Day 84 · Normal
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Stenosis at Day 84 Compared to Baseline
Pulmonary valve thickness - Day 84 · Mild
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Stenosis at Day 84 Compared to Baseline
Tricuspid valve - Baseline · Normal
|
6 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Stenosis at Day 84 Compared to Baseline
Tricuspid valve - Baseline · Mild
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Stenosis at Day 84 Compared to Baseline
Tricuspid valve - Day 84 · Normal
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Stenosis at Day 84 Compared to Baseline
Tricuspid valve - Day 84 · Mild
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 84Population: Full analysis set, participants in cohort 5 that received any study drug with a valid assessment for the outcome measure
Cardiac valve regurgitation severity on a four point ordinal scale. Categorized by imaging vendor into four semiquantitative (normal, mild, moderate and severe) categories
Outcome measures
| Measure |
BLZ945 300mg - Cohort 1 (Part 1)
n=6 Participants
BLZ945 300mg
|
BLZ945 600mg - Cohort 2 (Part 1)
n=6 Participants
BLZ945 600mg
|
BLZ945 800mg - Cohort 4 (Part 1)
BLZ945 800mg
|
BLZ945 1200mg - Cohort 3 (Part 1)
BLZ945 1200mg
|
BLZ945 800mg - Cohort 5 Arm #1 (Part 2)
BLZ945 800mg (4 days on/10 days off)
|
BLZ945 800mg - Cohort 5 Arm #2 (Part 2)
BLZ945 800mg (once weekly)
|
|---|---|---|---|---|---|---|
|
Cohort 5: Cardiac Valve Regurgitation Severity at Day 84 Compared to Baseline
Aortic valve - Baseline · Normal
|
5 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Regurgitation Severity at Day 84 Compared to Baseline
Aortic valve - Baseline · Mild
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Regurgitation Severity at Day 84 Compared to Baseline
Aortic valve - Day 84 · Normal
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Regurgitation Severity at Day 84 Compared to Baseline
Aortic valve - Day 84 · Mild
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Regurgitation Severity at Day 84 Compared to Baseline
Mitral valve - Baseline · Normal
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Regurgitation Severity at Day 84 Compared to Baseline
Mitral valve - Baseline · Mild
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Regurgitation Severity at Day 84 Compared to Baseline
Mitral valve - Day 84 · Normal
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Regurgitation Severity at Day 84 Compared to Baseline
Mitral valve - Day 84 · Mild
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Regurgitation Severity at Day 84 Compared to Baseline
Pulmonary valve - Baseline · Normal
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Regurgitation Severity at Day 84 Compared to Baseline
Pulmonary valve - Baseline · Mild
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Regurgitation Severity at Day 84 Compared to Baseline
Pulmonary valve - Day 84 · Normal
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Regurgitation Severity at Day 84 Compared to Baseline
Pulmonary valve - Day 84 · Mild
|
0 Participants
|
01 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Regurgitation Severity at Day 84 Compared to Baseline
Tricuspid valve - Baseline · Normal
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Regurgitation Severity at Day 84 Compared to Baseline
Tricuspid valve - Baseline · Mild
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Regurgitation Severity at Day 84 Compared to Baseline
Tricuspid valve - Day 84 · Normal
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Cohort 5: Cardiac Valve Regurgitation Severity at Day 84 Compared to Baseline
Tricuspid valve - Day 84 · Mild
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, day 84Population: Full analysis set, participants in cohort 5 that received any study drug with a valid assessment for the outcome measure
Mean change from baseline in Left Ventricular Ejection Fraction. LVEF is defined as the percentage of blood volume ejected from the left ventricle during systole (contraction phase) relative to the total volume of blood present in the ventricle at the end of diastole (relaxation phase).
Outcome measures
| Measure |
BLZ945 300mg - Cohort 1 (Part 1)
n=2 Participants
BLZ945 300mg
|
BLZ945 600mg - Cohort 2 (Part 1)
n=2 Participants
BLZ945 600mg
|
BLZ945 800mg - Cohort 4 (Part 1)
BLZ945 800mg
|
BLZ945 1200mg - Cohort 3 (Part 1)
BLZ945 1200mg
|
BLZ945 800mg - Cohort 5 Arm #1 (Part 2)
BLZ945 800mg (4 days on/10 days off)
|
BLZ945 800mg - Cohort 5 Arm #2 (Part 2)
BLZ945 800mg (once weekly)
|
|---|---|---|---|---|---|---|
|
Cohort 5: Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
|
1.533 Percentage of LVEF
Standard Deviation 2.9713
|
5.021 Percentage of LVEF
Standard Deviation 2.0796
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 84Population: Full analysis set, participants in cohort 5 that received any study drug
Number of patients with adverse events related to ECM accumulation
Outcome measures
| Measure |
BLZ945 300mg - Cohort 1 (Part 1)
n=6 Participants
BLZ945 300mg
|
BLZ945 600mg - Cohort 2 (Part 1)
n=6 Participants
BLZ945 600mg
|
BLZ945 800mg - Cohort 4 (Part 1)
BLZ945 800mg
|
BLZ945 1200mg - Cohort 3 (Part 1)
BLZ945 1200mg
|
BLZ945 800mg - Cohort 5 Arm #1 (Part 2)
BLZ945 800mg (4 days on/10 days off)
|
BLZ945 800mg - Cohort 5 Arm #2 (Part 2)
BLZ945 800mg (once weekly)
|
|---|---|---|---|---|---|---|
|
Cohort 5: Adverse Events Related to Extracellular Matrix (ECM) Accumulation
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 1-4: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours after BLZ945 dosing on Day 1 and Day 4. Cohort 5: pre-dose, 1, 2 and 4 hours after BLZ945 dosing on Day 1 (Arm#2 only) and Day 4 (Arm#1 only)Population: Participants in the PK analysis set with an available value for the outcome measure at the corresponding timepoint. The PK analysis set included all participants with at least one available valid PK concentration measurement, who received any study drug, and had no protocol deviations that impacted on PK data.
Measured by Cmax - The maximum plasma concentration of BLZ945
Outcome measures
| Measure |
BLZ945 300mg - Cohort 1 (Part 1)
n=4 Participants
BLZ945 300mg
|
BLZ945 600mg - Cohort 2 (Part 1)
n=4 Participants
BLZ945 600mg
|
BLZ945 800mg - Cohort 4 (Part 1)
n=4 Participants
BLZ945 800mg
|
BLZ945 1200mg - Cohort 3 (Part 1)
n=3 Participants
BLZ945 1200mg
|
BLZ945 800mg - Cohort 5 Arm #1 (Part 2)
n=4 Participants
BLZ945 800mg (4 days on/10 days off)
|
BLZ945 800mg - Cohort 5 Arm #2 (Part 2)
n=6 Participants
BLZ945 800mg (once weekly)
|
|---|---|---|---|---|---|---|
|
Cohorts 1-5: Plasma Pharmacokinetics (PK) of BLZ945 - Cmax
Day 1
|
6850 ng/mL of BLZ945
Standard Deviation 780
|
16000 ng/mL of BLZ945
Standard Deviation 2510
|
21100 ng/mL of BLZ945
Standard Deviation 5630
|
25900 ng/mL of BLZ945
Standard Deviation 2630
|
—
|
19900 ng/mL of BLZ945
Standard Deviation 5990
|
|
Cohorts 1-5: Plasma Pharmacokinetics (PK) of BLZ945 - Cmax
Day 4
|
12100 ng/mL of BLZ945
Standard Deviation 2300
|
25900 ng/mL of BLZ945
Standard Deviation 3440
|
30700 ng/mL of BLZ945
Standard Deviation 7800
|
37600 ng/mL of BLZ945
Standard Deviation 4270
|
22400 ng/mL of BLZ945
Standard Deviation 3120
|
—
|
SECONDARY outcome
Timeframe: Cohort 1-4: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours after BLZ945 dosing on Day 1 and Day 4. Cohort 5: pre-dose, 1, 2 and 4 hours after BLZ945 dosing on Day 1 (Arm#2 only) and Day 4 (Arm#1 only)Population: Participants in the PK analysis set with an available value for the outcome measure at the corresponding timepoint. The PK analysis set included all participants with at least one available valid PK concentration measurement, who received any study drug, and had no protocol deviations that impacted on PK data.
Measured by Tmax - Time to Reach the Maximum Concentration After Drug Administration of BLZ945. Actual recorded sampling times were taken into consideration for the calculation of PK parameters.
Outcome measures
| Measure |
BLZ945 300mg - Cohort 1 (Part 1)
n=4 Participants
BLZ945 300mg
|
BLZ945 600mg - Cohort 2 (Part 1)
n=4 Participants
BLZ945 600mg
|
BLZ945 800mg - Cohort 4 (Part 1)
n=4 Participants
BLZ945 800mg
|
BLZ945 1200mg - Cohort 3 (Part 1)
n=3 Participants
BLZ945 1200mg
|
BLZ945 800mg - Cohort 5 Arm #1 (Part 2)
n=4 Participants
BLZ945 800mg (4 days on/10 days off)
|
BLZ945 800mg - Cohort 5 Arm #2 (Part 2)
n=6 Participants
BLZ945 800mg (once weekly)
|
|---|---|---|---|---|---|---|
|
Cohorts 1-5: Plasma Pharmacokinetics (PK) of BLZ945 - Tmax
Day 1
|
1.02 hours
Interval 1.0 to 1.07
|
2.01 hours
Interval 1.0 to 2.08
|
2.01 hours
Interval 1.0 to 7.0
|
1.00 hours
Interval 1.0 to 1.0
|
—
|
2.00 hours
Interval 1.0 to 4.17
|
|
Cohorts 1-5: Plasma Pharmacokinetics (PK) of BLZ945 - Tmax
Day 4
|
1.01 hours
Interval 0.5 to 1.03
|
1.50 hours
Interval 1.0 to 4.0
|
3.00 hours
Interval 1.0 to 6.08
|
2.02 hours
Interval 1.0 to 4.0
|
1.49 hours
Interval 0.817 to 2.0
|
—
|
SECONDARY outcome
Timeframe: Cohort 1-4: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours after BLZ945 dosing on Day 1 and Day 4. Cohort 5: pre-dose, 1, 2 and 4 hours after BLZ945 dosing on Day 1 (Arm#2 only) and Day 4 (Arm#1 only)Population: Participants in the PK analysis set with an available value for the outcome measure at the corresponding timepoint. The PK analysis set included all participants with at least one available valid PK concentration measurement, who received any study drug, and had no protocol deviations that impacted on PK data.
Measured by AUC - Area under the curve of BLZ945 AUC0-24h is the AUC calculated from time zero to 24 hours after dosing (end of a dosing interval). AUClast is the AUC from time zero to the last measurable concentration sampling time.
Outcome measures
| Measure |
BLZ945 300mg - Cohort 1 (Part 1)
n=4 Participants
BLZ945 300mg
|
BLZ945 600mg - Cohort 2 (Part 1)
n=4 Participants
BLZ945 600mg
|
BLZ945 800mg - Cohort 4 (Part 1)
n=4 Participants
BLZ945 800mg
|
BLZ945 1200mg - Cohort 3 (Part 1)
n=3 Participants
BLZ945 1200mg
|
BLZ945 800mg - Cohort 5 Arm #1 (Part 2)
n=4 Participants
BLZ945 800mg (4 days on/10 days off)
|
BLZ945 800mg - Cohort 5 Arm #2 (Part 2)
n=6 Participants
BLZ945 800mg (once weekly)
|
|---|---|---|---|---|---|---|
|
Cohorts 1-5: Plasma Pharmacokinetics (PK) of BLZ945 - AUC
AUC 0-24h - Day 1
|
93000 hour * ng/mL
Standard Deviation 2510
|
204000 hour * ng/mL
Standard Deviation 28000
|
278000 hour * ng/mL
Standard Deviation 49600
|
391000 hour * ng/mL
Standard Deviation 10600
|
—
|
—
|
|
Cohorts 1-5: Plasma Pharmacokinetics (PK) of BLZ945 - AUC
AUC 0-24h - Day 4
|
175000 hour * ng/mL
Standard Deviation 14100
|
401000 hour * ng/mL
Standard Deviation 88700
|
535000 hour * ng/mL
Standard Deviation 157000
|
680000 hour * ng/mL
Standard Deviation 48300
|
—
|
—
|
|
Cohorts 1-5: Plasma Pharmacokinetics (PK) of BLZ945 - AUC
AUClast - Day 1
|
92600 hour * ng/mL
Standard Deviation 2750
|
203000 hour * ng/mL
Standard Deviation 26800
|
277000 hour * ng/mL
Standard Deviation 99500
|
34100 hour * ng/mL
Standard Deviation 91100
|
—
|
56900 hour * ng/mL
Standard Deviation 21400
|
|
Cohorts 1-5: Plasma Pharmacokinetics (PK) of BLZ945 - AUC
AUClast - Day 4
|
170000 hour * ng/mL
Standard Deviation 20300
|
399000 hour * ng/mL
Standard Deviation 87800
|
533000 hour * ng/mL
Standard Deviation 158000
|
671000 hour * ng/mL
Standard Deviation 43400
|
73400 hour * ng/mL
Standard Deviation 7710
|
—
|
SECONDARY outcome
Timeframe: Cohort 1-4: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours after BLZ945 dosing on Day 1 and Day 4.Population: Participants in the PK analysis set with an available value for the outcome measure at the corresponding timepoint. The PK analysis set included all participants with at least one available valid PK concentration measurement, who received any study drug, and had no protocol deviations that impacted on PK data.
Measured by T1/2 - The elimination half-life of BLZ945
Outcome measures
| Measure |
BLZ945 300mg - Cohort 1 (Part 1)
n=4 Participants
BLZ945 300mg
|
BLZ945 600mg - Cohort 2 (Part 1)
n=4 Participants
BLZ945 600mg
|
BLZ945 800mg - Cohort 4 (Part 1)
n=4 Participants
BLZ945 800mg
|
BLZ945 1200mg - Cohort 3 (Part 1)
n=3 Participants
BLZ945 1200mg
|
BLZ945 800mg - Cohort 5 Arm #1 (Part 2)
BLZ945 800mg (4 days on/10 days off)
|
BLZ945 800mg - Cohort 5 Arm #2 (Part 2)
BLZ945 800mg (once weekly)
|
|---|---|---|---|---|---|---|
|
Cohorts 1-4: Plasma Pharmacokinetics (PK) of BLZ945 - T1/2
Day 1
|
NA Hours
Standard Deviation NA
Not estimable because the R-squared of the terminal elimination phase was less than 0.75.
|
NA Hours
Standard Deviation NA
Not estimable because the R-squared of the terminal elimination phase was less than 0.75.
|
NA Hours
Standard Deviation NA
Not estimable because the R-squared of the terminal elimination phase was less than 0.75.
|
NA Hours
Standard Deviation NA
Not estimable because the R-squared of the terminal elimination phase was less than 0.75.
|
—
|
—
|
|
Cohorts 1-4: Plasma Pharmacokinetics (PK) of BLZ945 - T1/2
Day 4
|
NA Hours
Standard Deviation NA
Not estimable because the R-squared of the terminal elimination phase was less than 0.75.
|
NA Hours
Standard Deviation NA
Not estimable because the R-squared of the terminal elimination phase was less than 0.75.
|
NA Hours
Standard Deviation NA
Not estimable because the R-squared of the terminal elimination phase was less than 0.75.
|
NA Hours
Standard Deviation NA
Not estimable because the R-squared of the terminal elimination phase was less than 0.75.
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0-4, 4-8, 8-12 and 12-24 hours after BLZ945 dosing on Day 1 and Day 4Population: PK analysis set, participants with at least one available valid PK concentration measurement , who received any study drug, and had no protocol deviations that impact on PK data
Urine renal clearance (CLR) of BLZ945
Outcome measures
| Measure |
BLZ945 300mg - Cohort 1 (Part 1)
n=4 Participants
BLZ945 300mg
|
BLZ945 600mg - Cohort 2 (Part 1)
n=4 Participants
BLZ945 600mg
|
BLZ945 800mg - Cohort 4 (Part 1)
n=4 Participants
BLZ945 800mg
|
BLZ945 1200mg - Cohort 3 (Part 1)
n=3 Participants
BLZ945 1200mg
|
BLZ945 800mg - Cohort 5 Arm #1 (Part 2)
BLZ945 800mg (4 days on/10 days off)
|
BLZ945 800mg - Cohort 5 Arm #2 (Part 2)
BLZ945 800mg (once weekly)
|
|---|---|---|---|---|---|---|
|
Cohorts 1-4: Renal Clearance (CLR) of BLZ945
Day 1
|
0.00597 liter/hour (L/hr)
Standard Deviation 0.00184
|
0.00844 liter/hour (L/hr)
Standard Deviation 0.00675
|
0.00466 liter/hour (L/hr)
Standard Deviation 0.00312
|
0.0213 liter/hour (L/hr)
Standard Deviation 0.0258
|
—
|
—
|
|
Cohorts 1-4: Renal Clearance (CLR) of BLZ945
Day 4
|
0.00667 liter/hour (L/hr)
Standard Deviation 0.00127
|
0.00410 liter/hour (L/hr)
Standard Deviation 0.00205
|
0.00362 liter/hour (L/hr)
Standard Deviation 0.00262
|
0.00550 liter/hour (L/hr)
Standard Deviation 0.00129
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 daysPopulation: Full analysis set
Incidence and severity of AEs and SAEs by treatment group. AE grades to characterize the severity of the AEs were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. For CTCAE, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE
Outcome measures
| Measure |
BLZ945 300mg - Cohort 1 (Part 1)
n=4 Participants
BLZ945 300mg
|
BLZ945 600mg - Cohort 2 (Part 1)
n=4 Participants
BLZ945 600mg
|
BLZ945 800mg - Cohort 4 (Part 1)
n=4 Participants
BLZ945 800mg
|
BLZ945 1200mg - Cohort 3 (Part 1)
n=4 Participants
BLZ945 1200mg
|
BLZ945 800mg - Cohort 5 Arm #1 (Part 2)
n=6 Participants
BLZ945 800mg (4 days on/10 days off)
|
BLZ945 800mg - Cohort 5 Arm #2 (Part 2)
n=6 Participants
BLZ945 800mg (once weekly)
|
|---|---|---|---|---|---|---|
|
Cohorts 1-5: Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Study-drug related AEs leading to discontinuation of study treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Cohorts 1-5: Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Total AEs
|
2 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
|
Cohorts 1-5: Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE of grade 1
|
2 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
|
Cohorts 1-5: Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE of grade 2
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
|
Cohorts 1-5: Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE of grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
|
Cohorts 1-5: Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE of grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Cohorts 1-5: Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE of grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Cohorts 1-5: Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Study drug-related AEs
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
|
Cohorts 1-5: Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Serious AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Cohorts 1-5: Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs leading to discontinuation of study treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
Adverse Events
BLZ945 300mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BLZ945 600mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BLZ945 800mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BLZ945 1200mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm 1 (4/10)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm 2 (4/10) QW
Serious events: 4 serious events
Other events: 6 other events
Deaths: 2 deaths
Total
Serious events: 5 serious events
Other events: 24 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
BLZ945 300mg
n=4 participants at risk
BLZ945 300mg
|
BLZ945 600mg
n=4 participants at risk
BLZ945 600mg
|
BLZ945 800mg
n=4 participants at risk
BLZ945 800mg
|
BLZ945 1200mg
n=4 participants at risk
BLZ945 1200mg
|
Arm 1 (4/10)
n=6 participants at risk
Arm 1 (4/10)
|
Arm 2 (4/10) QW
n=6 participants at risk
Arm 2 (4/10) QW
|
Total
n=28 participants at risk
Total
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
33.3%
2/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
7.1%
2/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Investigations
Transaminases increased
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
33.3%
2/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
7.1%
2/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
Other adverse events
| Measure |
BLZ945 300mg
n=4 participants at risk
BLZ945 300mg
|
BLZ945 600mg
n=4 participants at risk
BLZ945 600mg
|
BLZ945 800mg
n=4 participants at risk
BLZ945 800mg
|
BLZ945 1200mg
n=4 participants at risk
BLZ945 1200mg
|
Arm 1 (4/10)
n=6 participants at risk
Arm 1 (4/10)
|
Arm 2 (4/10) QW
n=6 participants at risk
Arm 2 (4/10) QW
|
Total
n=28 participants at risk
Total
|
|---|---|---|---|---|---|---|---|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
50.0%
2/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
7.1%
2/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Investigations
Blood urine present
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Ear and labyrinth disorders
Vertigo positional
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Eye disorders
Eye irritation
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Eye disorders
Eye swelling
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
7.1%
2/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
7.1%
2/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
14.3%
4/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
7.1%
2/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
75.0%
3/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
50.0%
3/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
32.1%
9/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
10.7%
3/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
General disorders
Asthenia
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
General disorders
Fatigue
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
50.0%
2/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
50.0%
3/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
33.3%
2/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
28.6%
8/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
General disorders
Pain
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
General disorders
Swelling face
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Hepatobiliary disorders
Ocular icterus
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
7.1%
2/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Infections and infestations
Tooth infection
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
7.1%
2/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
33.3%
2/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
33.3%
2/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
17.9%
5/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
33.3%
2/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
7.1%
2/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
33.3%
2/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
14.3%
4/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Investigations
Faecal volume decreased
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Investigations
Transaminases increased
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Investigations
Troponin increased
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Investigations
Weight decreased
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
7.1%
2/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
7.1%
2/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Musculoskeletal and connective tissue disorders
Myokymia
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Nervous system disorders
Brain fog
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
7.1%
2/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Nervous system disorders
Dizziness
|
50.0%
2/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
50.0%
2/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
7/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
75.0%
3/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
50.0%
3/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
33.3%
2/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
35.7%
10/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Nervous system disorders
Migraine
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
7.1%
2/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
7.1%
2/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Nervous system disorders
Paraesthesia
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
7.1%
2/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Nervous system disorders
Somnolence
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
7.1%
2/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
7.1%
2/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Product Issues
Device dislocation
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
7.1%
2/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Psychiatric disorders
Panic attack
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
33.3%
2/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
7.1%
2/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
7.1%
2/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Vascular disorders
Haematoma
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
25.0%
1/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/4 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
16.7%
1/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
0.00%
0/6 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
3.6%
1/28 • From first dose of study treatment up to 32 days after last dose (Day 36) for Cohorts 1-4 and up to 4 weeks after last dose (Day 330) for Cohort 5. *Maximum duration of exposure in Cohort 5 was 302 days. 302 + 28 days of FU=330 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER