Trial Outcomes & Findings for COSMIC-HF - Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure (NCT NCT01786512)
NCT ID: NCT01786512
Last Updated: 2021-08-12
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
544 participants
Primary outcome timeframe
Day 7 at predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours, and 7 days post-dose.
Results posted on
2021-08-12
Participant Flow
Participants with chronic heart failure treated with stable, optimal pharmacological therapy for ≥ 4 weeks were enrolled from February 2013 to March 2015 at 86 centers in 13 countries in Europe, Australia, and North America. The study consisted of a dose-escalation phase to select 1 of 3 omecamtiv mecarbil (OM) oral formulations in 2 dose cohorts, and an expansion phase to evaluate 20 weeks of treatment with the selected formulation at 2 target dose levels, compared with placebo.
In each of the dose-escalation cohorts participants were randomized equally to receive 1 of the 3 formulations of OM or placebo. In the expansion phase participants were randomized equally to receive 25 mg oral OM twice daily (fixed-dose group), 25 mg oral OM twice daily titrated up to 50 mg twice daily (pharmacokinetic-titration group), or oral placebo. Randomization in both phases was stratified by presence or absence of atrial fibrillation/flutter.
Participant milestones
| Measure |
Dose-escalation Cohort 1: Placebo
Participants received placebo tablets twice a day (BID) for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1
Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2
Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2
Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Placebo
Participants received placebo tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1
Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
Expansion Phase: Placebo
Participants received placebo tablets twice a day for 20 weeks.
|
Expansion Phase: Omecamtiv Mecarbil 25 mg
Participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day for 20 weeks.
|
Expansion Phase: OM PK-based Titration
Participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day. At week 8 the dose escalated to 50 mg twice a day if the week 2 predose plasma concentration of OM was less than the predefined cutoff of 200 ng/mL.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
14
|
13
|
10
|
11
|
12
|
14
|
149
|
150
|
149
|
|
Overall Study
Received Study Treatment
|
11
|
10
|
14
|
13
|
10
|
11
|
11
|
14
|
149
|
150
|
146
|
|
Overall Study
COMPLETED
|
11
|
10
|
14
|
13
|
10
|
11
|
11
|
14
|
145
|
145
|
137
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
4
|
5
|
12
|
Reasons for withdrawal
| Measure |
Dose-escalation Cohort 1: Placebo
Participants received placebo tablets twice a day (BID) for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1
Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2
Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2
Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Placebo
Participants received placebo tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1
Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
Expansion Phase: Placebo
Participants received placebo tablets twice a day for 20 weeks.
|
Expansion Phase: Omecamtiv Mecarbil 25 mg
Participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day for 20 weeks.
|
Expansion Phase: OM PK-based Titration
Participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day. At week 8 the dose escalated to 50 mg twice a day if the week 2 predose plasma concentration of OM was less than the predefined cutoff of 200 ng/mL.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Decision by sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
3
|
7
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
1
|
3
|
Baseline Characteristics
COSMIC-HF - Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure
Baseline characteristics by cohort
| Measure |
Dose-escalation Cohort 1: Placebo
n=11 Participants
Participants received placebo tablets twice a day (BID) for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1
n=11 Participants
Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2
n=14 Participants
Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2
n=13 Participants
Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Placebo
n=10 Participants
Participants received placebo tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1
n=11 Participants
Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
n=12 Participants
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
n=14 Participants
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
Expansion Phase: Placebo
n=149 Participants
Participants received placebo tablets twice a day for 20 weeks.
|
Expansion Phase: Omecamtiv Mecarbil 25 mg
n=150 Participants
Participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day for 20 weeks.
|
Expansion Phase: OM PK-based Titration
n=149 Participants
Participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day. At week 8 the dose escalated to 50 mg twice a day if the week 2 predose plasma concentration of OM was less than the predefined cutoff of 200 ng/mL.
|
Total
n=544 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.5 years
STANDARD_DEVIATION 4.6 • n=99 Participants
|
67.7 years
STANDARD_DEVIATION 11.4 • n=107 Participants
|
65.3 years
STANDARD_DEVIATION 8.8 • n=206 Participants
|
66.7 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
62.1 years
STANDARD_DEVIATION 9.3 • n=31 Participants
|
65.1 years
STANDARD_DEVIATION 7.0 • n=30 Participants
|
63.8 years
STANDARD_DEVIATION 11.6 • n=3 Participants
|
64.3 years
STANDARD_DEVIATION 11.5 • n=6 Participants
|
63.7 years
STANDARD_DEVIATION 9.7 • n=114 Participants
|
62.8 years
STANDARD_DEVIATION 10.2
|
62.7 years
STANDARD_DEVIATION 11.7 • n=19 Participants
|
63.4 years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
|
Age, Customized
18 - 64 years
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
82 Participants
n=114 Participants
|
81 Participants
|
76 Participants
n=19 Participants
|
280 Participants
n=4 Participants
|
|
Age, Customized
65 - 74 years
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
46 Participants
n=114 Participants
|
52 Participants
|
50 Participants
n=19 Participants
|
188 Participants
n=4 Participants
|
|
Age, Customized
75 - 84 years
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
21 Participants
n=114 Participants
|
17 Participants
|
23 Participants
n=19 Participants
|
76 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
30 Participants
n=114 Participants
|
23 Participants
|
24 Participants
n=19 Participants
|
97 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
12 Participants
n=6 Participants
|
119 Participants
n=114 Participants
|
127 Participants
|
125 Participants
n=19 Participants
|
447 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
7 Participants
|
4 Participants
n=19 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
11 Participants
n=30 Participants
|
11 Participants
n=3 Participants
|
14 Participants
n=6 Participants
|
147 Participants
n=114 Participants
|
143 Participants
|
145 Participants
n=19 Participants
|
527 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
1 Participants
|
0 Participants
n=19 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
11 Participants
n=114 Participants
|
5 Participants
|
8 Participants
n=19 Participants
|
34 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
11 Participants
n=3 Participants
|
12 Participants
n=6 Participants
|
136 Participants
n=114 Participants
|
142 Participants
|
140 Participants
n=19 Participants
|
502 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
1 Participants
n=19 Participants
|
3 Participants
n=4 Participants
|
|
Stratification Factor - Atrial Fibrillation/Flutter at Randomization
Yes
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
32 Participants
n=114 Participants
|
32 Participants
|
32 Participants
n=19 Participants
|
107 Participants
n=4 Participants
|
|
Stratification Factor - Atrial Fibrillation/Flutter at Randomization
No
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
10 Participants
n=3 Participants
|
11 Participants
n=6 Participants
|
117 Participants
n=114 Participants
|
118 Participants
|
117 Participants
n=19 Participants
|
437 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 7 at predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours, and 7 days post-dose.Population: The pharmacokinetic analysis set (PKAS) included all randomized participants who received at least 1 dose of OM and had at least 1 evaluable OM PK parameter.
Outcome measures
| Measure |
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1
n=10 Participants
Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2
n=14 Participants
Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2
n=13 Participants
Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1
n=10 Participants
Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
n=11 Participants
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
n=14 Participants
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase: Maximum Observed Plasma Concentration (Cmax) of Omecamtiv Mecarbil Following the Last Dose (Day 7)
|
193 ng/mL
Standard Deviation 58.8
|
201 ng/mL
Standard Deviation 94.4
|
171 ng/mL
Standard Deviation 53.8
|
492 ng/mL
Standard Deviation 115
|
502 ng/mL
Standard Deviation 138
|
601 ng/mL
Standard Deviation 204
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7 at predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours, and 7 days post-dose.Population: Pharmacokinetic analysis set
Outcome measures
| Measure |
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1
n=10 Participants
Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2
n=14 Participants
Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2
n=13 Participants
Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1
n=10 Participants
Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
n=11 Participants
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
n=14 Participants
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase: Time to Maximum Observed Plasma Concentration (Tmax) of Omecamtiv Mecarbil Following the Last Dose (Day 7)
|
3.9 hours
Standard Deviation 4.4
|
2.0 hours
Standard Deviation 1.2
|
4.2 hours
Standard Deviation 1.9
|
2.6 hours
Standard Deviation 2.4
|
2.2 hours
Standard Deviation 1.8
|
4.6 hours
Standard Deviation 2.3
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7 at predosePopulation: Pharmacokinetic analysis set
Outcome measures
| Measure |
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1
n=10 Participants
Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2
n=14 Participants
Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2
n=13 Participants
Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1
n=10 Participants
Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
n=11 Participants
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
n=14 Participants
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase: Plasma Concentration of Omecamtiv Mecarbil Prior to Dosing on Day 7
|
157 ng/mL
Standard Deviation 63.7
|
137 ng/mL
Standard Deviation 56.8
|
134 ng/mL
Standard Deviation 54.7
|
376 ng/mL
Standard Deviation 170
|
395 ng/mL
Standard Deviation 108
|
476 ng/mL
Standard Deviation 234
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7 at predose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post-dosePopulation: Pharmacokinetic analysis set
Outcome measures
| Measure |
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1
n=10 Participants
Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2
n=14 Participants
Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2
n=13 Participants
Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1
n=10 Participants
Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
n=11 Participants
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
n=14 Participants
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase: Area Under the Plasma Concentration-time Curve for a Dosing Interval of 12 Hours Post Dose (AUC12) for Omecamtiv Mecarbil
|
2030 ng*hr/mL
Standard Deviation 658
|
2000 ng*hr/mL
Standard Deviation 1020
|
1740 ng*hr/mL
Standard Deviation 586
|
5070 ng*hr/mL
Standard Deviation 1060
|
5010 ng*hr/mL
Standard Deviation 1160
|
6550 ng*hr/mL
Standard Deviation 2340
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose (before morning dose) at weeks 2, 8, 12, 16, and 20Population: Pharmacokinetic analysis set with available data at each time point.
Outcome measures
| Measure |
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1
n=147 Participants
Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2
n=141 Participants
Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2
Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1
Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
|---|---|---|---|---|---|---|---|---|
|
Expansion Phase: Plasma Concentration of Omecamtiv Mecarbil Prior to Dosing
Week 2
|
174 ng/mL
Standard Deviation 62.2
|
179 ng/mL
Standard Deviation 68.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Expansion Phase: Plasma Concentration of Omecamtiv Mecarbil Prior to Dosing
Week 8
|
156 ng/mL
Standard Deviation 69.1
|
161 ng/mL
Standard Deviation 74.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Expansion Phase: Plasma Concentration of Omecamtiv Mecarbil Prior to Dosing
Week 12
|
165 ng/mL
Standard Deviation 67.9
|
263 ng/mL
Standard Deviation 116
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Expansion Phase: Plasma Concentration of Omecamtiv Mecarbil Prior to Dosing
Week 16
|
155 ng/mL
Standard Deviation 69.0
|
240 ng/mL
Standard Deviation 120
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Expansion Phase: Plasma Concentration of Omecamtiv Mecarbil Prior to Dosing
Week 20
|
149 ng/mL
Standard Deviation 71.2
|
239 ng/mL
Standard Deviation 118
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Weeks 2 and 12 at predose and 1, 2, 4, 6, and 8 hours post-dose.Population: Pharmacokinetic analysis set with available data at each time point.
Outcome measures
| Measure |
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1
n=147 Participants
Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2
n=141 Participants
Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2
Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1
Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
|---|---|---|---|---|---|---|---|---|
|
Expansion Phase: Maximum Observed Plasma Concentration of Omecamtiv Mecarbil
Week 2
|
212 ng/mL
Standard Deviation 70.4
|
212 ng/mL
Standard Deviation 81.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Expansion Phase: Maximum Observed Plasma Concentration of Omecamtiv Mecarbil
Week 12
|
200 ng/mL
Standard Deviation 71.1
|
318 ng/mL
Standard Deviation 129
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and week 20Population: The full analysis set (FAS) included all randomized participants who received at least 1 dose of study drug. The repeated-measures model included all observed values.
Systolic ejection time was measured using echocardiography. Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.
Outcome measures
| Measure |
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1
n=149 Participants
Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2
n=150 Participants
Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2
n=146 Participants
Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1
Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
|---|---|---|---|---|---|---|---|---|
|
Expansion Phase: Change From Baseline in Systolic Ejection Time (SET) at Week 20
|
0.0000 seconds
Standard Error 0.0025
|
0.0112 seconds
Standard Error 0.0024
|
0.0250 seconds
Standard Error 0.0026
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and week 20Population: The full analysis set included all randomized participants who received at least 1 dose of study drug. The repeated-measures model included all observed values.
Stroke volume was measured using echocardiography. Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.
Outcome measures
| Measure |
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1
n=149 Participants
Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2
n=150 Participants
Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2
n=146 Participants
Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1
Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
|---|---|---|---|---|---|---|---|---|
|
Expansion Phase: Change From Baseline in Stroke Volume at Week 20
|
-1.05 mL
Standard Error 1.18
|
3.53 mL
Standard Error 1.16
|
2.58 mL
Standard Error 1.19
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and week 20Population: The full analysis set included all randomized participants who received at least 1 dose of study drug. The repeated-measures model included all observed values.
LVESD was measured using echocardiography. Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.
Outcome measures
| Measure |
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1
n=149 Participants
Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2
n=150 Participants
Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2
n=146 Participants
Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1
Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
|---|---|---|---|---|---|---|---|---|
|
Expansion Phase: Change From Baseline in Left Ventricular End Systolic Diameter (LVESD) at Week 20
|
-0.242 cm
Standard Error 0.043
|
-0.322 cm
Standard Error 0.044
|
-0.421 cm
Standard Error 0.045
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and week 20Population: The full analysis set included all randomized participants who received at least 1 dose of study drug. The repeated-measures model included all observed values.
LVEDD was measured using echocardiography. Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.
Outcome measures
| Measure |
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1
n=149 Participants
Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2
n=150 Participants
Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2
n=146 Participants
Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1
Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
|---|---|---|---|---|---|---|---|---|
|
Expansion Phase: Change From Baseline in Left Ventricular End Diastolic Diameter (LVEDD) at Week 20
|
0.089 cm
Standard Error 0.038
|
0.023 cm
Standard Error 0.038
|
-0.040 cm
Standard Error 0.040
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and week 20Population: The full analysis set included all randomized participants who received at least 1 dose of study drug. The repeated-measures model included all observed values.
Heart rate was measured using electrocardiography. Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.
Outcome measures
| Measure |
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1
n=149 Participants
Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2
n=150 Participants
Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2
n=146 Participants
Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1
Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
|---|---|---|---|---|---|---|---|---|
|
Expansion Phase: Change From Baseline in Heart Rate at Week 20
|
0.57 bpm
Standard Error 0.79
|
-0.77 bpm
Standard Error 0.79
|
-2.40 bpm
Standard Error 0.81
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and week 20Population: The full analysis set included all randomized participants who received at least 1 dose of study drug. The repeated-measures model included all observed values.
Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.
Outcome measures
| Measure |
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1
n=149 Participants
Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2
n=150 Participants
Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2
n=146 Participants
Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1
Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
|---|---|---|---|---|---|---|---|---|
|
Expansion Phase: Change From Baseline in N-terminal Prohormone B-type Natriuretic Peptide (NT-proBNP) at Week 20
|
502 pg/mL
Standard Error 257
|
-319 pg/mL
Standard Error 257
|
-468 pg/mL
Standard Error 262
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase.Population: Participants randomized in the dose-escalation phase who received at least 1 dose of study drug.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant, including worsening of a preexisting medical condition. The event does not necessarily have a causal relationship with study treatment. Laboratory value changes that required treatment or adjustment in current therapy were considered adverse events. Each adverse event was graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE), where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, and Grade 4 = life-threatening AE. A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria: * fatal * life threatening * required in-patient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event
Outcome measures
| Measure |
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1
n=11 Participants
Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2
n=10 Participants
Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2
n=14 Participants
Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1
n=13 Participants
Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
n=10 Participants
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
n=11 Participants
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
n=11 Participants
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
n=14 Participants
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase: Number of Participants With Treatment-emergent Adverse Events
Any treatment-emergent adverse event (TEAE)
|
4 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
9 Participants
|
3 Participants
|
5 Participants
|
|
Dose Escalation Phase: Number of Participants With Treatment-emergent Adverse Events
TEAE Grade ≥ 2
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Dose Escalation Phase: Number of Participants With Treatment-emergent Adverse Events
TEAE Grade ≥ 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Dose Escalation Phase: Number of Participants With Treatment-emergent Adverse Events
TEAE Grade ≥ 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Dose Escalation Phase: Number of Participants With Treatment-emergent Adverse Events
Serious adverse events
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Dose Escalation Phase: Number of Participants With Treatment-emergent Adverse Events
TEAE leading to discontinuation of study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Dose Escalation Phase: Number of Participants With Treatment-emergent Adverse Events
Fatal adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug until 4 weeks after last dose; treatment duration was 20 weeks in the expansion phase.Population: All participants randomized in the expansion phase who received at least 1 dose of study drug.
An adverse event is defined as any untoward medical occurrence in a clinical trial participant, including worsening of a preexisting medical condition. The event does not necessarily have a causal relationship with study treatment. Laboratory value changes that required treatment or adjustment in current therapy were considered adverse events. Each adverse event was graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE), where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, and Grade 4 = life-threatening AE. A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria: * fatal * life threatening * required in-patient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event
Outcome measures
| Measure |
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1
n=149 Participants
Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2
n=150 Participants
Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2
n=146 Participants
Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1
Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
|---|---|---|---|---|---|---|---|---|
|
Expansion Phase: Number of Participants With Treatment-emergent Adverse Events
Any treatment-emergent adverse event (TEAE)
|
91 Participants
|
92 Participants
|
95 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Expansion Phase: Number of Participants With Treatment-emergent Adverse Events
TEAE Grade ≥ 2
|
62 Participants
|
60 Participants
|
61 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Expansion Phase: Number of Participants With Treatment-emergent Adverse Events
TEAE Grade ≥ 3
|
34 Participants
|
28 Participants
|
31 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Expansion Phase: Number of Participants With Treatment-emergent Adverse Events
TEAE Grade ≥ 4
|
5 Participants
|
8 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Expansion Phase: Number of Participants With Treatment-emergent Adverse Events
Serious adverse events
|
30 Participants
|
36 Participants
|
32 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Expansion Phase: Number of Participants With Treatment-emergent Adverse Events
TEAEs leading to discontinuation of study drug
|
12 Participants
|
8 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Expansion Phase: Number of Participants With Treatment-emergent Adverse Events
Fatal adverse events
|
4 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Dose-escalation Cohort 1: Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose-escalation Cohort 2: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Expansion Phase: Placebo
Serious events: 30 serious events
Other events: 48 other events
Deaths: 0 deaths
Expansion Phase: Omecamtiv Mecarbil 25 mg
Serious events: 36 serious events
Other events: 51 other events
Deaths: 0 deaths
Expansion Phase: OM PK-based Titration
Serious events: 32 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose-escalation Cohort 1: Placebo
n=11 participants at risk
Participants received placebo tablets BID for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1
n=10 participants at risk
Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2
n=14 participants at risk
Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2
n=13 participants at risk
Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Placebo
n=10 participants at risk
Participants received placebo tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1
n=11 participants at risk
Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
n=11 participants at risk
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
n=14 participants at risk
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
Expansion Phase: Placebo
n=149 participants at risk
Participants received placebo tablets twice a day for 20 weeks.
|
Expansion Phase: Omecamtiv Mecarbil 25 mg
n=150 participants at risk
Participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day for 20 weeks.
|
Expansion Phase: OM PK-based Titration
n=146 participants at risk
Participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day. At week 8 the dose escalated to 50 mg twice a day if the week 2 predose plasma concentration of OM was less than the predefined cutoff of 200 ng/mL.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.3%
2/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.0%
3/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.3%
2/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.3%
2/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac asthma
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.7%
4/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.0%
3/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
3.4%
5/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.0%
3/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.1%
3/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.0%
3/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.0%
3/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.0%
3/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.1%
3/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardio-respiratory distress
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.3%
2/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.3%
2/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Cardiac complication associated with device
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Chest discomfort
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Death
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Impaired healing
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.3%
2/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic congestion
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.1%
1/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.4%
2/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Gangrene
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.1%
1/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.1%
3/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Prostate infection
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ulnar nerve injury
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Troponin I increased
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Troponin increased
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.3%
2/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.4%
2/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ of skin
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma of the bladder
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.3%
2/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Dose-escalation Cohort 1: Placebo
n=11 participants at risk
Participants received placebo tablets BID for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1
n=10 participants at risk
Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2
n=14 participants at risk
Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2
n=13 participants at risk
Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Placebo
n=10 participants at risk
Participants received placebo tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1
n=11 participants at risk
Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
n=11 participants at risk
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
|
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
n=14 participants at risk
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
|
Expansion Phase: Placebo
n=149 participants at risk
Participants received placebo tablets twice a day for 20 weeks.
|
Expansion Phase: Omecamtiv Mecarbil 25 mg
n=150 participants at risk
Participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day for 20 weeks.
|
Expansion Phase: OM PK-based Titration
n=146 participants at risk
Participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day. At week 8 the dose escalated to 50 mg twice a day if the week 2 predose plasma concentration of OM was less than the predefined cutoff of 200 ng/mL.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
4.7%
7/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
6.0%
9/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
8.9%
13/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
6.0%
9/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.3%
2/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.1%
3/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.0%
3/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.0%
3/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.7%
4/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Sinus bradycardia
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.1%
1/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.3%
2/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.3%
2/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
3.4%
5/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
3.3%
5/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.7%
4/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.7%
1/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.3%
2/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.1%
1/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
3.4%
5/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.3%
2/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.5%
8/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
21.4%
3/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.3%
2/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.3%
2/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.4%
2/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.7%
4/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
9.3%
14/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
6.2%
9/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Feeling hot
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Nodule
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
3.4%
5/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.3%
8/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
3.4%
5/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.1%
1/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.3%
2/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Carotid bruit
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.1%
1/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Heart rate increased
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.1%
1/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
N-terminal prohormone brain natriuretic peptide increased
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Troponin I increased
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Weight increased
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Gout
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
4.0%
6/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.0%
3/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.4%
2/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
18.2%
2/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.7%
1/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.0%
3/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.3%
2/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
4.0%
6/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.3%
8/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
6.2%
9/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.1%
1/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
38.5%
5/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
18.2%
2/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
3.4%
5/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.3%
2/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
6.2%
9/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.7%
1/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.3%
2/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.3%
2/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.7%
1/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.3%
2/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.3%
2/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.4%
2/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.3%
2/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.0%
3/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.0%
1/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.1%
1/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.0%
3/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
3.4%
5/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/13 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/10 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
9.1%
1/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/11 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/149 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.67%
1/150 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.68%
1/146 • From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase and 20 weeks in the expansion phase.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER