Trial Outcomes & Findings for Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3773274 in Adults With Hypertrophic Cardiomyopathy (NCT NCT04219826)

NCT ID: NCT04219826

Last Updated: 2026-02-24

Results Overview

Participant incidence of reported AEs to determine the safety and tolerability of aficamten in participants with HCM.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

96 participants

Primary outcome timeframe

14 weeks

Results posted on

2026-02-24

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1 (oHCM) - Aficamten Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily	Cohort 1 (oHCM) - Placebo Participants received placebo once daily for up to 10 weeks Placebo for CK-3773274: Placebo administered orally once daily	Cohort 2 (oHCM) - Aficamten Participants received CK-3773274 doses 10 - 30 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (10 - 30 mg): CK-3773274 tablets administered orally once daily	Cohort 2 (oHCM) - Placebo Participants received placebo once daily for up to 10 weeks Placebo for CK-3773274: Placebo administered orally once daily	Cohort 3 (oHCM) - Aficamten & Background Disopyramide Participants received CK-3773274 doses 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks while taking disopyramide CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily	Cohort 4 (nHCM) - Aficamten Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily
Overall Study STARTED	14	8	14	6	13	41
Overall Study COMPLETED	14	6	14	6	13	39
Overall Study NOT COMPLETED	0	2	0	0	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 (oHCM) - Placebo Participants received placebo once daily for up to 10 weeks Placebo for CK-3773274: Placebo administered orally once daily	Cohort 4 (nHCM) - Aficamten Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily
Overall Study Protocol Violation	2	0
Overall Study Withdrawal by Subject	0	1
Overall Study Death	0	1

Baseline Characteristics

2 patients did not have baseline core lab read LVEFs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 (oHCM) - Aficamten n=14 Participants Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily	Cohort 1 (oHCM) - Placebo n=7 Participants Participants received placebo once daily for up to 10 weeks Placebo for CK-3773274: Placebo administered orally once daily	Cohort 2 (oHCM) - Aficamten n=14 Participants Participants received CK-3773274 doses 10 - 30 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (10 - 30 mg): CK-3773274 tablets administered orally once daily	Cohort 2 (oHCM) - Placebo n=6 Participants Participants received placebo once daily for up to 10 weeks Placebo for CK-3773274: Placebo administered orally once daily	Cohort 3 (oHCM) - Aficamten & Background Disopyramide n=13 Participants Participants received CK-3773274 doses 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks while taking disopyramide CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily	Cohort 4 (nHCM) - Aficamten n=41 Participants Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily	Total n=95 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=14 Participants	0 Participants n=7 Participants	0 Participants n=14 Participants	0 Participants n=6 Participants	0 Participants n=13 Participants	0 Participants n=41 Participants	0 Participants n=95 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=14 Participants	4 Participants n=7 Participants	9 Participants n=14 Participants	6 Participants n=6 Participants	9 Participants n=13 Participants	28 Participants n=41 Participants	64 Participants n=95 Participants
Age, Categorical >=65 years	6 Participants n=14 Participants	3 Participants n=7 Participants	5 Participants n=14 Participants	0 Participants n=6 Participants	4 Participants n=13 Participants	13 Participants n=41 Participants	31 Participants n=95 Participants
Sex: Female, Male Female	4 Participants n=14 Participants	6 Participants n=7 Participants	11 Participants n=14 Participants	2 Participants n=6 Participants	7 Participants n=13 Participants	24 Participants n=41 Participants	54 Participants n=95 Participants
Sex: Female, Male Male	10 Participants n=14 Participants	1 Participants n=7 Participants	3 Participants n=14 Participants	4 Participants n=6 Participants	6 Participants n=13 Participants	17 Participants n=41 Participants	41 Participants n=95 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=14 Participants	0 Participants n=7 Participants	0 Participants n=14 Participants	0 Participants n=6 Participants	1 Participants n=13 Participants	2 Participants n=41 Participants	3 Participants n=95 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=14 Participants	7 Participants n=7 Participants	14 Participants n=14 Participants	6 Participants n=6 Participants	12 Participants n=13 Participants	39 Participants n=41 Participants	92 Participants n=95 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=14 Participants	0 Participants n=7 Participants	0 Participants n=14 Participants	0 Participants n=6 Participants	0 Participants n=13 Participants	0 Participants n=41 Participants	0 Participants n=95 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=14 Participants	0 Participants n=7 Participants	0 Participants n=14 Participants	0 Participants n=6 Participants	0 Participants n=13 Participants	1 Participants n=41 Participants	1 Participants n=95 Participants
Race (NIH/OMB) Asian	0 Participants n=14 Participants	0 Participants n=7 Participants	0 Participants n=14 Participants	0 Participants n=6 Participants	1 Participants n=13 Participants	2 Participants n=41 Participants	3 Participants n=95 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants	0 Participants n=7 Participants	0 Participants n=14 Participants	0 Participants n=6 Participants	0 Participants n=13 Participants	0 Participants n=41 Participants	0 Participants n=95 Participants
Race (NIH/OMB) Black or African American	0 Participants n=14 Participants	0 Participants n=7 Participants	0 Participants n=14 Participants	1 Participants n=6 Participants	1 Participants n=13 Participants	8 Participants n=41 Participants	10 Participants n=95 Participants
Race (NIH/OMB) White	14 Participants n=14 Participants	7 Participants n=7 Participants	14 Participants n=14 Participants	5 Participants n=6 Participants	11 Participants n=13 Participants	27 Participants n=41 Participants	78 Participants n=95 Participants
Race (NIH/OMB) More than one race	0 Participants n=14 Participants	0 Participants n=7 Participants	0 Participants n=14 Participants	0 Participants n=6 Participants	0 Participants n=13 Participants	0 Participants n=41 Participants	0 Participants n=95 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=14 Participants	0 Participants n=7 Participants	0 Participants n=14 Participants	0 Participants n=6 Participants	0 Participants n=13 Participants	3 Participants n=41 Participants	3 Participants n=95 Participants
Region of Enrollment United States	13 Participants n=14 Participants	7 Participants n=7 Participants	13 Participants n=14 Participants	5 Participants n=6 Participants	13 Participants n=13 Participants	35 Participants n=41 Participants	86 Participants n=95 Participants
Region of Enrollment Spain	1 Participants n=14 Participants	0 Participants n=7 Participants	0 Participants n=14 Participants	0 Participants n=6 Participants	0 Participants n=13 Participants	5 Participants n=41 Participants	6 Participants n=95 Participants
Region of Enrollment Italy	0 Participants n=14 Participants	0 Participants n=7 Participants	1 Participants n=14 Participants	1 Participants n=6 Participants	0 Participants n=13 Participants	1 Participants n=41 Participants	3 Participants n=95 Participants
LVEF	73.2 % STANDARD_DEVIATION 5.6 • n=14 Participants • 2 patients did not have baseline core lab read LVEFs	76.8 % STANDARD_DEVIATION 6.7 • n=7 Participants • 2 patients did not have baseline core lab read LVEFs	75.4 % STANDARD_DEVIATION 6.4 • n=14 Participants • 2 patients did not have baseline core lab read LVEFs	71.9 % STANDARD_DEVIATION 4.5 • n=6 Participants • 2 patients did not have baseline core lab read LVEFs	74.2 % STANDARD_DEVIATION 7.5 • n=12 Participants • 2 patients did not have baseline core lab read LVEFs	69.8 % STANDARD_DEVIATION 7.2 • n=40 Participants • 2 patients did not have baseline core lab read LVEFs	72.4 % STANDARD_DEVIATION 7.0 • n=93 Participants • 2 patients did not have baseline core lab read LVEFs

PRIMARY outcome

Timeframe: 14 weeks

Population: Safety Analysis Set included all participants who received at least 1 dose of investigational product (IP), aficamten or placebo

Participant incidence of reported AEs to determine the safety and tolerability of aficamten in participants with HCM.

Outcome measures

Outcome measures
Measure	Cohort 1 (oHCM) - Aficamten n=14 Participants Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily	Cohort 1 (oHCM) - Placbo n=7 Participants Participants received placebo once daily for up to 10 weeks Placebo for CK-3773274: Placebo administered orally once daily	Cohort 2 (oHCM) - Aficamten n=14 Participants Participants received CK-3773274 doses 10 - 30 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (10 - 30 mg): CK-3773274 tablets administered orally once daily	Cohort 2 (oHCM) - Placebo n=6 Participants Participants received placebo once daily for up to 10 weeks Placebo for CK-3773274: Placebo administered orally once daily	Cohort 3 (oHCM) - Aficamten & Background Disopyramide n=13 Participants Participants received CK-3773274 doses 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks while taking disopyramide CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily	Cohort 4 (nHCM) - Aficamten n=41 Participants Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily
Incidence of Adverse Events (AEs)	10 Participants	7 Participants	11 Participants	4 Participants	9 Participants	28 Participants

PRIMARY outcome

Timeframe: 14 weeks

Population: Safety Analysis Set included all participants who received at least 1 dose of IP, aficamten or placebo

Participant incidence of LVEF \< 50% as assessed by the core laboratory assessment.

Outcome measures

Outcome measures
Measure	Cohort 1 (oHCM) - Aficamten n=14 Participants Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily	Cohort 1 (oHCM) - Placbo n=7 Participants Participants received placebo once daily for up to 10 weeks Placebo for CK-3773274: Placebo administered orally once daily	Cohort 2 (oHCM) - Aficamten n=14 Participants Participants received CK-3773274 doses 10 - 30 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (10 - 30 mg): CK-3773274 tablets administered orally once daily	Cohort 2 (oHCM) - Placebo n=6 Participants Participants received placebo once daily for up to 10 weeks Placebo for CK-3773274: Placebo administered orally once daily	Cohort 3 (oHCM) - Aficamten & Background Disopyramide n=13 Participants Participants received CK-3773274 doses 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks while taking disopyramide CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily	Cohort 4 (nHCM) - Aficamten n=41 Participants Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily
Incidence of Left Ventricular Ejection Fraction (LVEF) < 50%	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	3 Participants

PRIMARY outcome

Timeframe: 14 weeks

Population: Safety Analysis Set included all participants who received at least 1 dose of IP, aficamten or placebo

Participant incidence of reported SAEs to determine the safety and tolerability of aficamten in participants with symptomatic HCM.

Outcome measures

Outcome measures
Measure	Cohort 1 (oHCM) - Aficamten n=14 Participants Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily	Cohort 1 (oHCM) - Placbo n=7 Participants Participants received placebo once daily for up to 10 weeks Placebo for CK-3773274: Placebo administered orally once daily	Cohort 2 (oHCM) - Aficamten n=14 Participants Participants received CK-3773274 doses 10 - 30 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (10 - 30 mg): CK-3773274 tablets administered orally once daily	Cohort 2 (oHCM) - Placebo n=6 Participants Participants received placebo once daily for up to 10 weeks Placebo for CK-3773274: Placebo administered orally once daily	Cohort 3 (oHCM) - Aficamten & Background Disopyramide n=13 Participants Participants received CK-3773274 doses 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks while taking disopyramide CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily	Cohort 4 (nHCM) - Aficamten n=41 Participants Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily
Incidence of Serious Adverse Events (SAEs)	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline and 10 weeks

Population: The Pharmacodynamics Analysis Set (PDS) included all participants who received at least 1 dose of IP and had a baseline and at least 1 post-baseline core laboratory echocardiography assessment including non-missing LVEF measurements and non-missing LVOT-G at rest.

Concentration-response relationship of CK-3773274 on the resting LVOT-G on echocardiogram over 10 weeks of treatment in participants with (oHCM) obstructive hypertrophic cardiomyopathy (oHCM) (Cohorts 1, 2, 3 only)

Outcome measures

Outcome measures
Measure	Cohort 1 (oHCM) - Aficamten n=14 Participants Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily	Cohort 1 (oHCM) - Placbo n=14 Participants Participants received placebo once daily for up to 10 weeks Placebo for CK-3773274: Placebo administered orally once daily	Cohort 2 (oHCM) - Aficamten n=12 Participants Participants received CK-3773274 doses 10 - 30 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (10 - 30 mg): CK-3773274 tablets administered orally once daily	Cohort 2 (oHCM) - Placebo Participants received placebo once daily for up to 10 weeks Placebo for CK-3773274: Placebo administered orally once daily	Cohort 3 (oHCM) - Aficamten & Background Disopyramide Participants received CK-3773274 doses 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks while taking disopyramide CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily	Cohort 4 (nHCM) - Aficamten Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily
Slope of the Relationship of the Plasma Concentration of CK-3773274 to the Change From Baseline in the Resting Left Ventricular Outflow Track Gradient (LVOT-G)	-0.1018 mmHg per ng/ML Interval -0.1394 to -0.0642	-0.0173 mmHg per ng/ML Interval -0.0325 to -0.0021	-0.0582 mmHg per ng/ML Interval -0.1029 to -0.0135	—	—	—

SECONDARY outcome

Timeframe: Baseline and 10 Weeks

Concentration-response relationship of CK-3773274 on the post-Valsalva LVOT-G on echocardiogram over 10 weeks of treatment in participants with oHCM (Cohorts 1, 2, 3 only)

Outcome measures

Outcome measures
Measure	Cohort 1 (oHCM) - Aficamten n=14 Participants Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily	Cohort 1 (oHCM) - Placbo n=14 Participants Participants received placebo once daily for up to 10 weeks Placebo for CK-3773274: Placebo administered orally once daily	Cohort 2 (oHCM) - Aficamten n=12 Participants Participants received CK-3773274 doses 10 - 30 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (10 - 30 mg): CK-3773274 tablets administered orally once daily	Cohort 2 (oHCM) - Placebo Participants received placebo once daily for up to 10 weeks Placebo for CK-3773274: Placebo administered orally once daily	Cohort 3 (oHCM) - Aficamten & Background Disopyramide Participants received CK-3773274 doses 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks while taking disopyramide CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily	Cohort 4 (nHCM) - Aficamten Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily
Slope of the Relationship of the Plasma Concentration of CK-3773274 to the Change From Baseline in the Post-Valsalva LVOT-G	-0.0902 mmHg per ng/ML Interval -0.1391 to -0.0413	-0.0538 mmHg per ng/ML Interval -0.0765 to -0.031	-0.1396 mmHg per ng/ML Interval -0.2144 to -0.0649	—	—	—

SECONDARY outcome

Timeframe: Baseline and 10 Weeks

Dose response relationship on resting LVOT-G of CK-3773274 in participants with oHCM (Cohorts 1, 2, 3 only)

Outcome measures

Outcome measures
Measure	Cohort 1 (oHCM) - Aficamten n=14 Participants Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily	Cohort 1 (oHCM) - Placbo n=6 Participants Participants received placebo once daily for up to 10 weeks Placebo for CK-3773274: Placebo administered orally once daily	Cohort 2 (oHCM) - Aficamten n=14 Participants Participants received CK-3773274 doses 10 - 30 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (10 - 30 mg): CK-3773274 tablets administered orally once daily	Cohort 2 (oHCM) - Placebo n=5 Participants Participants received placebo once daily for up to 10 weeks Placebo for CK-3773274: Placebo administered orally once daily	Cohort 3 (oHCM) - Aficamten & Background Disopyramide n=12 Participants Participants received CK-3773274 doses 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks while taking disopyramide CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily	Cohort 4 (nHCM) - Aficamten Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily
Change From Baseline in Resting LVOT-G Over Time as a Function of Dose. Placebo	—	-19.2 mmHg Standard Deviation 30.3	—	-0.5 mmHg Standard Deviation 11.5	—	—
Change From Baseline in Resting LVOT-G Over Time as a Function of Dose. 5 mg QD	-23.8 mmHg Standard Deviation 17.0	—	—	—	-16.0 mmHg Standard Deviation 15.3	—
Change From Baseline in Resting LVOT-G Over Time as a Function of Dose. 10 mg QD	-48.6 mmHg Standard Deviation 31.1	—	-53.1 mmHg Standard Deviation 38.9	—	-22.6 mmHg Standard Deviation 14.3	—
Change From Baseline in Resting LVOT-G Over Time as a Function of Dose. 15 mg QD	-45.5 mmHg Standard Deviation 27.2	—	—	—	-39.5 mmHg Standard Deviation 26.9	—
Change From Baseline in Resting LVOT-G Over Time as a Function of Dose. 20 mg QD	—	—	-30.8 mmHg Standard Deviation 27.7	—	—	—
Change From Baseline in Resting LVOT-G Over Time as a Function of Dose. 30 mg QD	—	—	-3.1 mmHg Standard Deviation NA Standard deviation not defined when n=1	—	—	—

SECONDARY outcome

Timeframe: 10 weeks

Dose response relationship of CK-3773274 on post-Valsalva LVOT-G in participants with symptomatic oHCM (Cohorts 1, 2, 3 only)

Outcome measures

Outcome measures
Measure	Cohort 1 (oHCM) - Aficamten n=14 Participants Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily	Cohort 1 (oHCM) - Placbo n=6 Participants Participants received placebo once daily for up to 10 weeks Placebo for CK-3773274: Placebo administered orally once daily	Cohort 2 (oHCM) - Aficamten n=14 Participants Participants received CK-3773274 doses 10 - 30 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (10 - 30 mg): CK-3773274 tablets administered orally once daily	Cohort 2 (oHCM) - Placebo n=5 Participants Participants received placebo once daily for up to 10 weeks Placebo for CK-3773274: Placebo administered orally once daily	Cohort 3 (oHCM) - Aficamten & Background Disopyramide n=12 Participants Participants received CK-3773274 doses 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks while taking disopyramide CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily	Cohort 4 (nHCM) - Aficamten Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily
Change From Baseline in Post-Valsalva LVOT-G Over Time as a Function of Dose. 30 mg QD	—	—	18.6 mmHg Standard Deviation NA Standard deviation not defined when n=1	—	—	—
Change From Baseline in Post-Valsalva LVOT-G Over Time as a Function of Dose. 15 mg QD	-48.2 mmHg Standard Deviation 20.4	—	—	—	-35.7 mmHg Standard Deviation 44.1	—
Change From Baseline in Post-Valsalva LVOT-G Over Time as a Function of Dose. 20 mg QD	—	—	-38.4 mmHg Standard Deviation 37.5	—	—	—
Change From Baseline in Post-Valsalva LVOT-G Over Time as a Function of Dose. Placebo	—	-10.5 mmHg Standard Deviation 24.9	—	-3.0 mmHg Standard Deviation 8.6	—	—
Change From Baseline in Post-Valsalva LVOT-G Over Time as a Function of Dose. 5 mg QD	-23.1 mmHg Standard Deviation 28.7	—	—	—	-43.8 mmHg Standard Deviation 40.6	—
Change From Baseline in Post-Valsalva LVOT-G Over Time as a Function of Dose. 10 mg QD	-35.1 mmHg Standard Deviation 32.1	—	-66.7 mmHg Standard Deviation 41.3	—	-13.5 mmHg Standard Deviation 18.1	—

SECONDARY outcome

Timeframe: Day 1 to End of Study (EOS) (Week 14)

Concentration-response relationship of CK-3773274 on LVEF over 10 weeks of treatment in participants with HCM

Outcome measures

Outcome measures
Measure	Cohort 1 (oHCM) - Aficamten n=14 Participants Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily	Cohort 1 (oHCM) - Placbo n=14 Participants Participants received placebo once daily for up to 10 weeks Placebo for CK-3773274: Placebo administered orally once daily	Cohort 2 (oHCM) - Aficamten n=12 Participants Participants received CK-3773274 doses 10 - 30 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (10 - 30 mg): CK-3773274 tablets administered orally once daily	Cohort 2 (oHCM) - Placebo n=40 Participants Participants received placebo once daily for up to 10 weeks Placebo for CK-3773274: Placebo administered orally once daily	Cohort 3 (oHCM) - Aficamten & Background Disopyramide Participants received CK-3773274 doses 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks while taking disopyramide CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily	Cohort 4 (nHCM) - Aficamten Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily
Slope of the Relationship of the Plasma Concentration of CK-3773274 to the Change From Baseline in the Resting LVEF	-0.0222 percentage per ng/ML Interval -0.0331 to -0.0114	-0.0200 percentage per ng/ML Interval -0.0276 to -0.0124	-0.0154 percentage per ng/ML Interval -0.0285 to -0.0023	-0.0105 percentage per ng/ML Interval -0.0153 to -0.0056	—	—

Adverse Events

Cohort 1 (oHCM) - Aficamten

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Cohort 1 (oHCM) - Placebo

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Cohort 2 (oHCM) - Aficamten

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Cohort 2 (oHCM) - Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort 3 (oHCM) - Aficamten & Background Disopyramide

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Cohort 4 (nHCM) - Aficamten

Serious events: 4 serious events

Other events: 26 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 (oHCM) - Aficamten n=14 participants at risk Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily	Cohort 1 (oHCM) - Placebo n=7 participants at risk Participants received placebo once daily for up to 10 weeks Placebo for CK-3773274: Placebo administered orally once daily	Cohort 2 (oHCM) - Aficamten n=14 participants at risk Participants received CK-3773274 doses 10 - 30 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (10 - 30 mg): CK-3773274 tablets administered orally once daily	Cohort 2 (oHCM) - Placebo n=6 participants at risk Participants received placebo once daily for up to 10 weeks Placebo for CK-3773274: Placebo administered orally once daily	Cohort 3 (oHCM) - Aficamten & Background Disopyramide n=13 participants at risk Participants received CK-377327 doses 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks while taking disopyramide CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily	Cohort 4 (nHCM) - Aficamten n=41 participants at risk Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily
Vascular disorders Hypotension	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 1/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Cardiac disorders Stress cardiomyopathy	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 1/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Cardiac disorders Acute coronary syndrome	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Cardiac disorders Atrial fibrillation	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	2.4% 1/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Cardiac disorders Cardiac arrest	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	2.4% 1/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Nervous system disorders Syncope	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 1/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Immune system disorders Myasthenia gravis	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	2.4% 1/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 1/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 1/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Infections and infestations Bronchitis	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	2.4% 1/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.

Other adverse events

Other adverse events
Measure	Cohort 1 (oHCM) - Aficamten n=14 participants at risk Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily	Cohort 1 (oHCM) - Placebo n=7 participants at risk Participants received placebo once daily for up to 10 weeks Placebo for CK-3773274: Placebo administered orally once daily	Cohort 2 (oHCM) - Aficamten n=14 participants at risk Participants received CK-3773274 doses 10 - 30 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (10 - 30 mg): CK-3773274 tablets administered orally once daily	Cohort 2 (oHCM) - Placebo n=6 participants at risk Participants received placebo once daily for up to 10 weeks Placebo for CK-3773274: Placebo administered orally once daily	Cohort 3 (oHCM) - Aficamten & Background Disopyramide n=13 participants at risk Participants received CK-377327 doses 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks while taking disopyramide CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily	Cohort 4 (nHCM) - Aficamten n=41 participants at risk Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 (5 - 15 mg): CK-3773274 tablets administered orally once daily
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	15.4% 2/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	4.9% 2/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Pruritus	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Urticaria	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Rash	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	2.4% 1/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Ear and labyrinth disorders Tinnitus	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Eye disorders Visual impairment	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 1/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Eye disorders Dry eye	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	16.7% 1/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Investigations Blood creatine phosphokinase increased	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Investigations Blood lactate dehydrogenase increased	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Investigations Blood magnesium decreased	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	2.4% 1/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Investigations Blood potassium decreased	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Investigations N-terminal prohormone brain natriuretic peptide increased	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Investigations Weight increased	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	16.7% 1/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Investigations Electrocardiogram PR prolongation	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Investigations International normalised ratio increased	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Investigations Prothrombin time prolonged	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 1/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Renal and urinary disorders Glycosuria	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Renal and urinary disorders Pollakiuria	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Renal and urinary disorders Dysuria	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Vascular disorders Hypertension	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 1/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	2.4% 1/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Immune system disorders Seasonal allergy	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	16.7% 1/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Nervous system disorders Dizziness postural	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Nervous system disorders Migraine	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Diarrhoea	14.3% 2/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 1/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	4.9% 2/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Bowel movement irregularity	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 1/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Dry mouth	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	33.3% 2/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Dyspepsia	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Nausea	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 1/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	16.7% 1/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.3% 3/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Constipation	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	2.4% 1/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Defaecation urgency	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Flatulence	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal distension	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	4.9% 2/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
General disorders Fatigue	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 1/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	17.1% 7/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
General disorders Chest discomfort	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	2.4% 1/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
General disorders Complication associated with device	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
General disorders Non-cardiac chest pain	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
General disorders Oedema peripheral	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 2/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
General disorders Pyrexia	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
General disorders Chills	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
General disorders Peripheral swelling	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Psychiatric disorders Abnormal dreams	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 1/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Psychiatric disorders Sleep disorder	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Psychiatric disorders Anxiety	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 1/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Psychiatric disorders Insomnia	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 1/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Cardiac disorders Atrial fibrillation	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 1/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Cardiac disorders Palpitations	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 1/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.3% 3/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Cardiac disorders Tachycardia	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Cardiac disorders Angina pectoris	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	4.9% 2/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Cardiac disorders Bradycardia	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Neck pain	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 1/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	14.3% 2/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	2.4% 1/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	16.7% 1/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	2.4% 1/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	15.4% 2/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Infections and infestations Nasopharyngitis	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	2.4% 1/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 1/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	2.4% 1/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Infections and infestations COVID-19	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.3% 3/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Infections and infestations Bronchitis	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Infections and infestations Pertussis	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Infections and infestations Pneumonia	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Infections and infestations Urinary tract infection	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	4.9% 2/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Contusion	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Fall	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 1/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Scratch	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 1/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 1/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.7% 1/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	4.9% 2/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 2/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	15.4% 2/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	4.9% 2/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 1/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Nervous system disorders Headache	21.4% 3/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	42.9% 3/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	16.7% 1/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	15.4% 2/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	2.4% 1/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Nervous system disorders Dizziness	21.4% 3/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 1/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 2/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	9.8% 4/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Nervous system disorders Paraesthesia	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 1/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.
Nervous system disorders Syncope	7.1% 1/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	14.3% 1/7 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/14 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/13 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.	0.00% 0/41 • Up to 14 weeks Safety Analysis Set: included all participants who received at least one dose of study treatment.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Cytokinetics agreement with investigators vary; constant is Cytokinetics' right to review communications regarding trial results prior to public release. Cytokinetics does not prohibit investigators from publishing, but single-center publications must be postponed until after release of the first multi-center publication for the trial. Investigators may not disclose previously undisclosed confidential information other than study data and results from their site.
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